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Title:
APPARATUS AND METHOD FOR MEASURING PHYSIOLOGICAL PARAMETERS
Document Type and Number:
WIPO Patent Application WO/2022/013901
Kind Code:
A1
Abstract:
An apparatus for the measurement of physiological parameters comprising: - a detector of the variability of the heartbeat frequency (HRV) connected to the individual under examination; - an isoinertial sensor (SEN) comprising a motion sensor that can be positioned at the height of the lumbar area of the individual under examination; - a central unit (UC) connected in input to said heartbeat rate variability (HRV) detector and to said isoinertial sensor (SEN) and equipped with software (AEG) capable of supplying a value (V1, V2, V3, V4) corresponding to the combined evaluation of the incoming data received, in which the data provided by the heart rate variability (HRV) detector are correlated to the evaluation of the state of the autonomic peripheral nervous system and the data provided by the isoinertial sensor (SEN) are related to the evaluation of the state of the somatic peripheral nervous system.

Inventors:
CHELLINI ANDREA (IT)
Application Number:
PCT/IT2021/050219
Publication Date:
January 20, 2022
Filing Date:
July 14, 2021
Export Citation:
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Assignee:
CHELLINI ANDREA (IT)
International Classes:
A61B5/0537; A61B5/00; A61B5/0205; A61B5/024; A61B5/053; A61B5/083; A61B5/11
Domestic Patent References:
WO2009063463A22009-05-22
Foreign References:
US20180310877A12018-11-01
EP3387989A12018-10-17
Attorney, Agent or Firm:
MINCONE, Antimo (IT)
Download PDF:
Claims:
CLAIMS

1. Apparatus for the measurement of physiological parameters that can be used to determine, through the combination of measured values and comparison of these values with reference values, the general state of health of an individual in its complexity, i.e. to obtain a general value that takes into account the interactions between the autonomic peripheral nervous system and the somatic peripheral nervous system, apparatus characterized in that it includes:

- a heart rate variability (HRV) detector linked to the individual under examination;

- an isoinertial sensor (SEN) comprising a motion sensor that can be positioned at the height of the lumbar area of the individual under examination;

- a central unit (UC) connected in input to said heart rate variability (HRV) detector and to said isoinertial sensor (SEN) and equipped with software (ALG) capable of supplying a value (VI, V2, V3, V4) corresponding to the combined evaluation of the incoming data received and in which the data provided by the heart rate variability (HRV) detector are correlated to the evaluation of the state of the autonomic peripheral nervous system and the data provided by the isoinertial sensor (SEN) are related to the evaluation of the state of the somatic peripheral nervous system.

2. Apparatus according to claim 1, characterized in that it comprises a capnograph (CAP) connected to the inlet of said central unit (UC) and capable of detecting a CO2 value of the individual under examination.

3. Apparatus according to claim 1, characterized in that it comprises means (MI) for entering data relating to a maximum apnea value of the individual under examination.

4. Apparatus according to one of the preceding claims, characterized in that said isoinertial sensor (SEN) comprises one or more static sensors.

5. Apparatus according to one of the preceding claims, characterized in that said isoinertial sensor (SEN) provides data relating to a frequency.

6. Apparatus according to one of the preceding claims, characterized in that it also comprises one or more devices of the group comprising:

- an adipometer (ADI) ,

- a bioimpedance meter (BIA) and

- a hair bulb analyzer (SDR).

7. Apparatus according to one of the claims preceding, characterized in that the software (ALG) adapted to process the received data incoming from said central unit (UC) is set in such a way to be consider standard values the following measurements: - for the heart rate variability (HRV) detector: VLF value of approximately 23 (± 5)% , LF value of approximately 25 (± 5)%, HF value of approximately 51 (± 5)% , with a rMSSD value between 40 (± 5) and 60 (± 5);

- for any capnograph (CAP) a value of mmHg CO2 ³ 36 mmHg;

- for any “maximum apnea” value, a value greater than 40 seconds.

8. Apparatus according to one of the preceding claims, characterized in that said heart frequency variability (HRV) detector is connected to the individual under examination by means of electrodes.

9. Apparatus according to one of the preceding claims, characterized in that said capnograph (CAP) is connected to the individual under examination by means of tubes to the nostrils.

10. Apparatus according to one of the preceding claims, characterized in that the values of said a adipometro (ADI) and / or of said measuring bioimpedance (BIA) are provided in image format.

11. Apparatus according to one of the preceding claims, characterized in that the data received from said heart rate variability detector (HRV) and from said capnograph (CAP) are used for evaluations relating to the autonomic nervous system (I) so as to define a cardio-pulmonary oscillator and the data received from said isoinertial sensor (SEN) are used for evaluations relating to the somatic nervous system (II) in order to define a kinesthetic oscillator.

12. Apparatus according to one of the preceding claims, characterized in that said central unit (UC) uses data relating to the frequencies.

13. Apparatus according to one of claims 1 to 11, characterized in that said one central unit (UC) uses values related to the frequencies provided by the detector of the variability of the heart frequency (HRV) and values related to the frequencies provided by the isoinertial sensor ( SEN).

14. Apparatus according to claim 13, characterized in that said isoinertial sensor (SEN) provides a data relating to a frequency with a time dependent function in the frequency domain.

15. Method for measuring physiological parameters that can be used to determine, through the combination of measured values and comparison of these values with reference values, the general state of health of an individual in its complexity, or to obtain a general value that takes into account the interactions between the autonomic peripheral nervous system and the somatic peripheral nervous system, method characterized in that it includes the following steps:

- detect the variability of the heartbeat rate linked to the individual under examination by means of a heartbeat rate variability (HRV) detector;

- detect a movement value by means of an isoinertial sensor (SEN) comprising a movement sensor positioned at the height of the lumbar area of the individual under examination;

- use a central unit (UC) , connected in input to said heart rate variability detector (HRV) and to said isoinertial sensor (SEN), and equipped with software (ALG) capable of supplying a value (VI, V2, V3, V4) corresponding to the combined evaluation of the incoming data received and in which the data provided by the heart rate variability (HRV) detector are correlated to the evaluation of the state of the autonomic peripheral nervous system and the data provided from the isoinertial sensor (SEN) are related to the evaluation of the state of the somatic peripheral nervous system.

16. Method according to claim 15, characterized in that said central unit (UC) uses data relating to the frequencies.

17. Method according to claim 15, characterized in that said central unit (UC) uses frequency values provided by the heartbeat rate variability (HRV) detector and frequency values provided by the isoinertial sensor (SEN).

18. Method according to one of claims 15 to 17, characterized in that the software (ALG) suitable for processing the data received from said central unit (UC) is set up in such a way as to consider the following measurements in the standard:

- for the heart rate variability (HRV) detector: VLF value of approximately 23 (± 5)% , LF value of approximately 25 (± 5)%, HF value of approximately 51 (± 5)% , with a rMSSD value between 40 (± 5) and 60 (± 5);

- for any capnograph (CAP) a value of mmHg C02 > 36 mmHg;

- for any “maximum apnea” value, a value greater than 40 seconds.

Description:
TITLE

Apparatus and method for measuring physiological parameters.

DESCRIPTION

The present invention relates to an apparatus and a method for measuring physiological parameters. In particular, the present invention is intended to provide an instrument capable of measuring pre-established physiological values in order to determine, through their combined evaluation and comparison with reference values, the general state of health of an individual in its complexity, i.e. to obtain a general value which takes into account the interactions between the peripheral autonomic nervous system and the somatic nervous system.

The description of the apparatus object of the invention will be preceded by an introduction relating to the scientific approach to the subject matter in order to better understand the approach underlying the innovative concept of the invention and, consequently, of the operation of the apparatus.

As will become clearer from the present description, it is possible to state that the apparatus of the invention constitutes an innovative apparatus capable of objectively and regularly assessing, by synchronising them, the peripheral autonomic nervous system and the peripheral somatic nervous system, comparing the results obtained with the general state of health, highlighted by the measurement of epigenetic damage that may be present on the entire complex system of the "human machine". Similarly, the method object of the present invention allows the peripheral autonomic nervous system and the peripheral somatic nervous system to be evaluated objectively and regularly, synchronising them.

It is necessary to take into consideration that the nervous system has the task of simulating the environment through the data it receives from both inside and outside the body (surrounding environment). These "data" are understood in the form of energy, emitted and received in a complex and non-linear manner.

The apparatus and the method of the invention are based on the concepts of quantum physics, already widely used in medical diagnostics, e.g. in MRI, using parameters such as magnetic fields, oscillations, frequencies, rhythms.

It is well known that our body emits electric fields due to the action potential of each neuron, which emits energy due to the change in charge between the inside and outside of the cell membrane. This moving electric field results in the activation of a coordinated magnetic field, as visible in the graph of Fig. 2. The magnetic field can be measured by the oscillation frequencies it generates; oscillatory “rhythms” can therefore be defined. Our body has central rhythm generators located centrally, in the CNS bulb (medulla oblongata) and in the spinal cord. A central rhythm generator presupposes the existence of a neural network potentially capable of self-generating a periodic stimulus because it has oscillatory capacities.

At the encephalic level, at least four oscillators related to walking, breathing, swallowing and chewing can be considered.

From the analysis of the experimental data it can be assumed that locomotor movements originate from a central rhythmic generator located at the midbrain level (midbrain locomotor region), acting on other hierarchically dependent nuclear structures at the spinal level, endowed with an oscillating activity necessary for the production of movement. This generator is in turn controlled by a sub-thalamic locomotion structure capable of modulating its oscillations.

The subthalamic locomotor region receives information from the pallidum and premotor cortex and is connected in output with the midbrain locomotor region in facilitative terms and with the substantia nigra in inhibitory terms.

This central generator would come into action at the beginning of the locomotor act producing the onset of walking.

The locomotor region of the midbrain (identified in this description by the acronym GCR, which stands for " Generatore Centrale del Ritmo", corresponding to the English term CPG "Central Pattern Generator") includes the cuneiform nucleus, the locus coeruleus, the substantia nigra and the median nuclei of the rate and has numerous efferent pathways: the one of greatest importance for locomotion is the ventrolateral funiculus (ventrolateral reticulo-spinal pathways, lateral vestibulo-spinal pathways, cerulean- spinal pathways).

Most GCRs involve the existence of interconnected centres.

In the GCR of locomotion there are centres capable of generating the flexion phase, and others that are capable of inducing the extensor phase of the step. The rhythmic output signals do not seem to reach the motoneurons directly, but to produce the step, pre- motoneuronal integration stations are probably used, connected both with the GCR of the walking, and with the encephalic systems in charge of the control of the voluntary movement, and with the plurimetameric and monometameric reflex arcs. The afferent input is, in this case, necessary only to select the times and characteristics of the locomotor scheme and to carry out, in case of variations of the forces acting on the receptive system, the necessary adjustments to the rhythmic and self-generated executive programme.

The central rhythmic generator of locomotion is also easily modifiable by the signals coming from cortical and striatal structures capable of making the gait pattern more intentional, which is generally completely automated. Even if they are not necessary to generate walking, the afferent signals coming from the periphery perform accessory tasks, capable of adapting the locomotor system to the environment; this task is accomplished by:

- the facilitation of the nuclei of locomotion (GCR) during the different phases of the step;

- modification of the excitability and excitation times of the locomotion nuclei (GCR);

- the enhancement of the inhibition of already inhibited nuclei in the context of the activation of the oscillating system;

- coordination between functionally coupled motor nuclei;

- the modulation of reflex systems depending on the phase of the step;

- the realisation of adaptive compensations to the environment through the exploitation of spinal and supraspinal reflex arcs (see influence of the vestibular nuclei);

- sending information to the cortical centres responsible for processing the external proprioceptive stimulus.

During walking there is a marked metabolic activity also at cerebellar level and it is evident an increase of the discharge frequency at the level of the dorsal and ventral spino cerebellar and spino-reticulo-cerebellar pathways.

A large amount of ascending information is sent to the encephalic structures especially through the dorsal and ventral spino-cerebellar pathways.

In particular, the dorsal spino-cerebellar pathways would be able to send information on the activity of the muscles, while the ventral spino-cerebellar tract would be able to transmit information on the activity of the locomotion program generator. One of the tasks of the cerebellum in controlling walking is to regulate the phase of the gait and to modulate coordination between the limbs. The nuclei of the base and in particular the striatum, are also involved in locomotor control, the ventral pallidus nucleus intervenes in the research movements related to memory and emotional situations, while the fibres coming from the caudate nucleus, if stimulated by the prefrontal cortex, activate locomotor behaviours towards motivating elements. The role of the cerebral cortex in gait control is not yet fully defined; however, the anterior frontal cortex seems to play an inhibitory role with respect to walking, while the pyramidal cells of area 4 seem to control the duration of the locomotor cycle by reducing the time of unipodal stance.

The neurons that give rise to the cortico-mbro-spinal pathway, to the cortico-reticulo- spinal and vestibulo-spinal pathways, are however rhythmically excited during the different phases of locomotion as well as the noradrenergic neurons of the locus coemleus are particularly active .

The locomotor GCR, in addition to activating the alpha motor neurons connected with the gait pattern, simultaneously activates the gamma motor neurons related to these and the intemeurons responsible for reciprocal and recurrent inhibition.

It can therefore be said that a gait is phrased in through a coactivation alpha / gamma system in order to leave time constantly in a state of receptivity. The co-activation of the alpha/gamma system is also present in other rhythmic motor activities such as chewing and breathing. In conditions of alpha/gamma coactivation, the maintenance of the spindle tension allows the nervous system to be receptive to the variations of tension and stretching of the muscles for the entire phase of the step cycle, so as to maintain intact the flow of proprioceptive afferent information. In particular, the peripheral proprioceptive afferences are not necessary for the locomotion with rectilinear motion in the flat ground, and they acquire significance in the directional inversion processes of the walk, in the variation of the speed and in the processes of adaptation to the ground. The presence of afferent activity, capable of influencing the locomotor GCR, in a certain phase of the gait cycle does not mean, however, that this must or can produce similar responses in other and different phases of the gait cycle. This phenomenon is particularly evident in the case of nociceptive stimuli, since a nociceptive stimulus applied to the sole of the foot in the monopodalic stance phase, does not produce the response in triple flexion, in order to avoid the subsequent fall, while the same stimulus applied to the swinging foot produces an immediate potentiation of the flexion attitude. An identical afferent discharge can therefore be channelled into different reflex circuits depending on the phase in which it reaches the spinal cord.

The existence of a 'central programme' that regulates the rhythmic action of walking without the need for afferent feed-back for its determinism has been confirmed by experiments. For example, in spinal animals whose afferent pathway was interrupted (such as cutting the dorsal roots responsible for innervation of the limbs), a normal motor output was observed at the level of the motor neurons. The recording of the bioelectrical activity of the muscles showed that, in addition to the flexo-extensor alternating activation, the temporal appropriateness of the muscle activity was also realised. In animals in which only the spinal cord was connected to the limbs, it was possible to make them walk on a moving platform with a speed dependent solely on the movement of the platform itself: the central programme was located in the spinal cord.

Although it has features that allow the generation of motor patterns, locomotion requires continuous afferent feedback for its normal performance. The afferents are essential in the global programme of locomotion, and an abnormality of the afferents leads to dysfunctions such as altered walking rhythms, which are much slower, and changes in the time course and details of motor patterns.

In the light of new findings in neuroscience, it can be said that ours is a “brain that acts”, not a “brain that thinks”. Continuous development, neuroplasticity, new neuronal connections, cognition, are the result of continuous actuation in the environment. The innate problem-solving capacity is only adopted when humans are able to move around in the environment, keep the brain supplied with energy (about 25% of the total caloric consumption of the body) and adapt, therefore, to the stimuli and challenges that the environment continually poses.

This adaptive capacity of the human being, which is also relative to higher mammals, determines the lifestyle.

For example, as set out by S. W. Porges in “The Polyvagal Theory”, unlike us, reptiles adopt a “sit and wait” strategy. Their autonomic nervous system almost totally blocks the supply of energy, and their metabolism drops, in a situation similar to that in which a snake waits for its victim. In contrast, the human being, having a powerful heart divided into four chambers, can easily adapt to the environment, with a constant supply of energy to the brain that can continue in its cognitive, knowledge activity. Reptiles, on the contrary, not having much energetic power, do not put a vagal brake on the heart. On the contrary, the dorsal vagus (also indicated by the acronym dmnX "dorsal motor nucleus of the vagus") takes over overwhelmingly, slowing down vital rhythms, blocking movement, inhibiting and slowing down breathing to a minimum. On the contrary, the human being uses the vagal efference - myelinated vagus NA - (ambiguous nucleus) as a kind of brake, to inhibit, manage, control the metabolic potential of this energy-intensive system. The “high”, active, responsive vagal tone (or high frequency HF) allows mammals to remain calm in the environment, not hyperventilate, not lower CO 2 levels too much, keep the brain supplied with oxygen.

The human vagal tone (HF) works well, at its maximum, when the individual is in quiet situations, in the company of peers and family members, while sleeping, etc.; however, the same tone is reduced when the individual has to face high-level environmental stimuli, related to survival, for example facing a predator, crossing a river in flood, running away from danger.

This is detected by measuring heart rate variation or HRV (Hearth Rate Variability), and the greater the frequency variation in the oscillation values, the more positive and indicative of health it is.

In relation to HRV measurement, it was once believed that the resting heart rate was monotonous and regular (e.g. 60 beats per minute would result in one beat per second). Subsequently, cardiological research revealed that there is a difference in contraction time between beats of a few milliseconds. This spontaneous change in the rate of cardiac contraction has been shown to be related to the pressure interactions of respiratory activity and the influences exerted by the branches of the sympathetic and parasympathetic nervous systems on the heart muscle. A healthy body with a healthy cardiovascular system will, at rest, show a striking irregularity between heartbeats and considerable heart rate variability (HRV); conversely, an organism under chronic stress will have a very regular heart rate with little variation. In other words, heart rate variability (HRV) is an important indicator of autonomic nervous system activity.

As expressed above, the aim of the present invention is to provide an instrument and a method capable of measuring pre-established physiological values to determine, through their combined evaluation and comparison with reference values, the general state of health of an individual in its complexity, that is, to obtain a general value which takes into account the interactions between the peripheral autonomic nervous system and the somatic nervous system.

This result is obtained by means of an apparatus and a method having the characteristics of the independent claims. Other advantageous features of the invention are described in the dependent claims.

Among the advantages of the present invention may be listed the following: the apparatus and the method allow to know in a substantially objective way the state of stress in which the examined individual is; the apparatus and the method succeed, in an innovative and original way, in combining the data obtainable from a HRV detection with the detection of inertial sensors and with the optional detection of a capnograph, with the possibility of verifying the results obtained by means of other devices suitable for measuring the state of stress such as, for example, an adipometer, a bioimpedance meter, optionally a hair bulb analyser; with the results provided by the equipment and the method, it is possible to size the quantity and quality of both Bottom up and Performance training before cumulative psychophysiological effects occur in the form of exhaustion or a decrease in psychophysical and athletic performance; thanks to the data provided by the equipment, it is possible to achieve synchronisation of the internal oscillatory systems, with consequent high physical and psychological benefits as it is possible to optimise the functions of the respiratory, cardiovascular, hormonal and immune systems, as well as a considerable saving in energy; it is possible to use the apparatus and the method in question to assess the effects on the peripheral nervous system of particular pathologies, including neurological ones.

These and further advantages and features of the present invention will be better understood by every person skilled in the art from the following description and with the help of the attached drawings, given as a practical example of the invention, but not to be considered in a limiting sense, in which:

- Fig. 1 is a diagram relating to a possible subdivision of the human nervous system;

- Fig. 2 is a diagram showing the connection between an electric field (E) and a magnetic field (B);

- Fig. 3 is a block diagram which represents a possible example of embodiment of an apparatus made in accordance with the present invention.

With reference to the attached drawings which represent only a scheme of possible embodiment of the invention, an apparatus (1) according to the invention can be used for measuring physiological parameters of an individual. In particular, the apparatus (1) can be used to determine, through the combination of measured values and the comparison of these values with reference values, the general state of health of an individual in its complexity, i.e. to obtain a general value which also takes into account the interactions between the autonomic peripheral nervous system and the somatic one.

In Fig. 1, the autonomic peripheral nervous system is schematically identified by the discontinuous circle (I) and the somatic one by the circle (II).

The diagram of Fig. 1 shows a main block, placed above, which represents the Nervous System; the two blocks “Central nervous system” (encephalon and spinal cord) and “Peripheral nervous system" branch off from the Nervous System block. From block “Peripheral nervous system” derive the block “Autonomic Nervous System” (which controls the internal organs and glands) and the block “Somatic Nervous System” (which is connected with the sense organs and voluntary muscles). Finally, in the lower level in the drawing of Fig. 1, the “Autonomic Nervous System” block branches into the two “Ortosympathetic” (delegated to: excitement, emergency, attack, escape or fear) and “Parasympathetic” (delegated a: quiet, relaxation, digestion, rest), while the “Somatic Nervous System” block branches into the two “Sensory - afferent” ( which sends sensory stimuli to the Central Nervous System ) and “Motor - efferent” ( which sends the commands to the voluntary muscles ).

The apparatus includes:

- a heart rate variability (HRV) detector linked to the individual under examination;

- an isoinertial sensor (SEN) comprising a motion sensor that can be positioned at the height of the lateral condyle area of the femur of the individual under examination;

- optionally a capnograph or capnometer (CAP) capable of detecting a CO2 value of the individual under examination;

- a central unit (UC) connected in input to said detector of the variability of the heartbeat frequency (HRV), to said isoinertial sensor (SEN) and, optionally, to said capnograph (CAP) and provided with a software (ALG) capable to output a value (VI, V2, V3, V4) corresponding to the combined evaluation of the data received at the input.

In particular, the inventor has experimentally ascertained that the signals received by the heart rate variability (HRV) detector can be advantageously used for an evaluation of the autonomic peripheral nervous system, while the signals received by the isoinertial sensor (SEN) can be advantageously used for an evaluation of the somatic peripheral nervous system.

The apparatus (1) is therefore advantageously provided with an isoinertial sensor (SEN) connected to the input of said central unit and comprising a movement sensor that can be positioned at the level of the area of the lateral condyle of the femur, alternatively right and left of the individual under examination. In particular, the isoinertial sensor (SEN) is provided with a band or other device for attachment to the human body so as to allow its association and detection at the aforementioned area. The sensor (SEN) is a motion sensor and gyroscope and provides a data relative and associated to a frequency related to the oscillatory phase characterising the Forward Locomotor Movement, precisely extracted from a Leg Raise test exercise. In fig. 3, the reference (2) indicates the detector devices just described. It is possible to state that the data received from said heart rate variability (HRV) detector (and optionally those received from the CAP capnograph) are used for evaluations related to the autonomic nervous system (I) in order to define a cardio-pulmonary oscillator and the data received from said isoinertial sensor (SEN) are used for evaluations relating to the somatic nervous system (II) in order to define a kinesthetic oscillator.

The data obtained from the capnograph (CAP) can be replaced by manually entering a value relating to the maximum apnea interval held by the person under examination. In practice, according to this mode of use, the central unit (UC) will not use a signal received by the capnograph (CAP) but a manually entered value that indicates the maximum apnea resistance of the subject under examination. The data will be expressed in seconds and the system will process them based on the software algorithm (ALG). The experimental data obtained by the applicant showed a close correlation between the values of “maximum pause” and the actual content of CO2 detectable instrumentally with a capnometric device, namely an instrument capable of performing a measurement of the composition and pressure ratios of exhaled air.

Manual data entry is represented by the block (MI) in Fig. 3.

In addition to the devices indicated with (2), the apparatus can advantageously comprise at least one of the devices of the group comprising:

- an adipometer (ADI),

- a bioimpedance meter (BIA) e

- a hair bulb analyzer (SDR).

The adipometer (ADI) is an instrument designed to measure the fat of the person and consists of an ultrasound-type probe capable of providing information relating to the fat present which, in addition to nutrition, can be determined by hormonal causes or to stressful situations.

The bioimpedance meter (BIA) can consist of an instrument which, based on the presence of intercellular water, provides a value relating to the impedance of the body.

The hair bulb analyzer (SDR) can be of the type known by the name “S -DRIVE” and able to provide information on the state of the individual under examination. The S-Drive device uses an oscillating coil and works by converting the frequencies of natural waves (called “signatures”) from the hair samples into a digital file that is sent to an informative centre where a computer, through an algorithm, decodes, encodes and digitizes the signature wave that emanates from its resonance with the hair follicle and then reads it. The process is relevant to the acquired epigenetic data. Relevance data can be used to create report charts and tables.

The test allows to evaluate in what conditions the organism is with respect to the main environmental components to which we are constantly subjected in excess or deficiency both with the diet and the environment that surrounds us. It therefore allows to adjust our needs in relation to what we come into contact with.

At the data level, the software (ALG) adapted to process the received data input from the central unit (UC) is set to consider in the standard, the following findings:

- for the heart rate variability (HRV) detector: VLF value of approximately 23 (± 5)% , LF value of approximately 25 (± 5)%, HF value of approximately 51 (± 5)% , with a rMSSD value between 40 (± 5) and 60 (± 5);

- for the capnograph (CAP) a value of mmHg CO2 ³ 36 mmHg or a maximum apnea value greater than 40 seconds.

The heart rate variability (HRV) detector is connected to the individual under examination preferably by electrodes.

Furthermore, the capnograph (CAP) is connected to the individual in question preferably by means of tubes to the nostrils, while the values of the adipometer (ADI) and/or the bioimpedance meter (BIA) are preferably provided in image format. Obviously in the absence of a capnograph (CAP) a keyboard, a touch screen or other means will be used to enter a value relating to the maximum apnea.

It is possible to state that the data received from the heart rate variability (HRV) detector (and optionally from the CAP capnograph or those related to maximum apnea) are used for evaluations related to the autonomic nervous system (I) in order to define a cardio pulmonary oscillator and the data received from the isoinertial sensor (SEN) are used for evaluations related to the somatic nervous system (II) in order to define a kinesthetic oscillator.

Other characteristics of the invention will be described below with examples suitable for better understanding the advantages.

The analysis of heart rate variability (HRV) makes it possible to understand, in a short space of time (in the order of minutes), the state of activity of the Autonomic Nervous System and to know whether there is hyper- or hypo-activity, which is not functional, of one of the two branches and to intervene to re-establish the correct balance.

The data relating to the trend of cardiac dynamics allow to acquire a series of quantitative and qualitative information from which it is possible to understand the state of the Autonomic Nervous System. The different types of analysis in the time and heart rate domains provide specific indicators with multiple values.

For example, in the time domain, the most widely known and used by athletes and those who need to maintain high intellectual performance is the rMSSD (root Mean Square of the Successive Differences), which measures the activity of the parasympathetic system over a specific time period. A low rMSSD value indicates low parasympathetic activity and difficulty in recovering from physical exertion or a high emotional stress situation.

In the frequency domain, the most interesting data is related to the 3 cardiac oscillation zones, each of which reflects specific activities of the Autonomic Nervous System:

- Very Low Frequency band - VLF, includes oscillations between 0.0033 and 0.03 Hz, represents the slowest changes in the heartbeat and is directly correlated with the activities of body thermoregulation and the hormonal cycle;

- Low Frequency band - LF, includes oscillations between 0.03 and 0.15 Hz, represents the slowest changes in heart rate and is an index of sympathetic activity, and the effectiveness of the baroreceptor loop, between the cardiovascular and respiratory systems, in the Hz band;

- High Frequency - HF band, comprising oscillations between 0.15 and 0.40 Hz, represents the fastest changes due to parasympathetic activity.

It has been shown that periods of chronic stress generate an increase in heart rates in the low frequency band with a loss of activity in the high frequency band, reflecting the natural increase in activity of the sympathetic system at the expense of the parasympathetic system.

The knowledge, on the part of a sportsman or an individual in general, of this data can give a great advantage in sizing the quantity and quality of training before cumulative psychophysiological effects occur, in the form of exhaustion or a decrease in athletic performance.

In the overall analysis of an individual’s state of health and stress, it is necessary to take into account the fact that the emotion, as a response to an environmental stimulus, is nothing more than energy, which in the form of activation potential is trapped in both mind and body, creating “trauma”.

Using Peter A. Levine's definition (see Peter A. Levine "Somatic Experience"), trauma is nothing but blocked energy, not what happens, but what we hold back in the absence of an empathic witness. For this reason, in-depth knowledge of the principles and neurophysiological activation and role of our autonomic nervous system, in a constant and ever-present “embodied cognition”, has led the applicant of this patent application to seek clinical measurement properties of the autonomic and somatic nervous system. For example, the possibility of knowing the functionality, for the purposes of survival, of the temporary dissociation that occurs in a situation of the type known as “Temporary Over Freezing” and how to intervene in a professional network, makes all the difference in the technological era we are living in, where this condition of the Peripheral Nervous System is very present and prevalent.

In other words, being able to combine the effects and operational consequences of Temporary Over Freezing with the functions conquered in evolution by the myelinated part of the vagus (NA) is the achievement of a methodological process based on neurophysiological principles adapted to the modernity of environmental stimuli - emotions - energy - which the individual is called upon to face today.

The results provided by the apparatus in question (generically indicated in Fig. 3 with the output values VI, V2, V3 and V4) allow to verify the presence of any stress conditions not justified by the real environmental and social conditions. In other words, it is possible to identify those situations of apparent but not real danger, known as “paper tigers”, differentiating them from real situations of danger, called “real tigers”, in which the individual must be in conditions of actively react when his organism consequently produces the physiological stimuli necessary to cancel this dangerous situation or at least to limit its consequences by bringing himself into a situation of “Freezing with fear”. On the other hand, in the event that the individual is subject to the influx of worries, thoughts, in a synthetic word “anxiety”, thanks to the action of the myelinated NA vagus nerve, the condition will be that called "Light Freezing", that is of “Freezing without Fear”, characterized by a modest bodily dissociation from the environment. The persistence of this condition determines an unnecessary activation of some functions such as, for example, those of the endocrine and immune systems that will be more active than necessary, causing a state of general fatigue not justified by the need for necessarily active behaviour. For example, it is possible to have a dissociative state characteristic of “Temporary Over Freezing”, in which the human system temporarily detaches itself from the environment, with a condition in which the brain, which is still in action, detaches and dissociates the body precisely to be able to use energy to get out of this Freezing condition and at the same time save it for the “internal physiological circuits” such as the continuous activation of the hypothalamic -pituitary-adrenal axis, avoiding activations and pre-activations that will never result in movement, energy, output. The absence of a solution to this problem can lead to a condition, called “Over Freezing”, in which the individual is unable to escape from the extreme protective state, thus not being able to face the environment, if not with the use of aids external, a physiological condition recognized in animals when they are in a point of “danger” from which there is no way back.

One of the principles underlying the present invention relates to the reactivity of the individual. For example, in a healthy, young subject, the vague NA is reactive, quick to activate and deactivate. When recognizes the dangerous stimulus, “right” (the so-called “real tiger”) , frees the sympathetic, conceding the maximum power to the activation of defences, with a “embolied” drive, of thought and movement. The reactivity and the fast “flush out” of the sympathetic system, once the danger is over, causes the vague NA to immediately restart its activity as a “brake”, or rather as a manager and regulator of the enormous potential that our metabolic system guarantees.

The problem that is often encountered is that this flush out does not happen today, not so quickly and effectively. In other words, the so-called “paper tigers” are constants determining anxieties and sadness, depressive states of the mood or other feelings to which it is not possible to provide an adequate response because they are not related to real dangers. In this condition it can add a real fear, unexpected, which turns into anxiety, concurring to raise the values of the sympathetic branch LF.

These just described are important steps: although we are permeated by continuous and daily paper tigers, it is also possible to have emotional states of fear like a real tiger, in which the freezing of fear is activated, the vague NA cancels itself, autonomously releases the “brake” to give way to maximum metabolic power. Unfortunately, the ensuing physical activation often does not occur, or at least not sufficiently to release all the energy available. The release of glycocorticoids following adenohypophysis input with ACTH lasts for tens of minutes. As soon as the danger has passed, we resume our life activity, hyperventilating for several minutes or even hours. In practice, in these cases the body has put in place a series of cascade systems to ensure the necessary energy (maximum aerobic power, given by phosphates), with possible subsequent hyperventilation, noradrenaline, CRH; in the following minutes it releases hormones from the cortical of the adrenal gland (cortisol), to guarantee energy, elevated vasopressin and aldosterone to contain liquids at both kidney and systemic level; blood coagulation to prevent leakage, blockage of digestion, refinement of the telereceptors, hearing, set to more receptive frequencies.

In conclusion, there is an activation which will never be “released” (freezing) and which will be added to any other freezing.

The immune system will immediately respond with the process of inflammatory information, which is as useful in the acute phase as it is harmful in the chronic phase. This chronic activation (which is also characterised by symptoms, such as chronic fatigue) is inferred from blood markers (IL6) and symptoms (insomnia, suboptimal defecation) and a vertical lowering of the immune defences, starting above all with Ig salivary and laryngo -pharyngeal duct, as a sentinel of systemic and general inflammation. The detection of cardiopulmonary and kinaesthetic oscillators is to be understood as a photograph, an immediately clear "frame" that tells us about the instant of life of the client/patient and that also gives us a presumable history of the "whole film", it makes us guess and deduce frame after frame, the "identity" of the SN of the individual, assuming that for no one the "film" is ever the same.

In case the subject is pervaded by a high anxiety, derived from real, environmental, or "cognitively" constructed fear, with VAGAL brake released (HF low values, LF high values) we will find outcomes in the body from activated striated musculature: cervicals "blocked" in movement, related migraines, night and day bruxism, hyperventilation, pelvic floor hyperactivation, hip flexor hyperactivation (psoas in primis), retracted feet in the vault from backfoot life line hyperactivation.

If there is a strong preponderance of the VAGO NA nerve (HF high values, LF low values), we will find activated smooth muscles, inferred from related symptoms and pathologies: hypertension, irritable colon, gastroesophageal reflux, asthma, sleep apnoea. It is clear that every individual living in the developed western world can present more symptoms, related to stress conditions with fear and without fear, with vague NA, the brake, either strongly activated, or released.

These are today's living conditions, which simulate constant “real” tigers and constant “paper” tigers.

For this reason, the survey is useful even if it is unique, but it is very useful if it is carried out constantly day after day, because it provides us with the history and the summation of the “real tigers” and the “paper tigers”.

So an individual can report somatic symptoms related to both smooth and striated muscle hyperactivation at the same time. In the case in which the vagus NA works intensely, brakes, partially immobilizes and at almost continuous moments, with the body that takes in energy, without having the possibility of releasing it immediately, both limbic (place of emotions) and of movement, we have a state that is defined as "light freezing". This state is assessed with the present invention by means of the cardiopulmonary and kinaesthetic oscillators mentioned above. If the condition of "light freezing" persists, i.e. if the individual is unable to limit the strong activation of the NA vagus in response to continuous stress from multiple sources, it possible to enter into a condition of "temporary over freezing". This condition is very frequent in our society, especially in categories of workers who suffer a lot of stress, connected and added to their social life. There are times when this condition is present that is sometimes called bum out; well, in these cases the cardiopulmonary detection system speaks clearly to us in comparison with the kinaesthetic oscillator.

The values of both LF - sympathetic - and HF - vagus NA -, are very low. The VLF, presumably the PNEI, reaches very high values. Moreover, at the level of Glycocorticoids/PNEI, the system often appears "healthy", physiological, if the "temporary over freezing" is temporary, if it does not last more than 2/3 days.

Only the CO2 measured with the capnometer (CAP) remains low in values, below the 36 mm/Hg reference, while the hormonal system performs a rapid flush out, aesthetically characterised only by an accumulation of extracellular liquids and the usual lack of urination in the early morning.

In this case, a device-based assessment (BIA) might be optimal, to directly assess extracellular versus intracellular water.

For everyone, the condition of continuous braking to external stress can lead to the most dangerous condition, called "NA vagus brake exhaustion".

If the paper tigers increase, through lack of movement and coaching and over time add up together with the continuous real tigers, marked by peaks of anxious stress, the brake becomes exhausted and ends, with the activation of the vagus dorsal DMNX, going towards a condition of over freezing, following the so-called "Default Hierarchy", always aimed at energy saving and general allostasis (the immune system "works" too much in the continuous activation-regulation passages between sympathetic and parasympathetic/Vagus NA).

A detail that can be decisive in the evaluation of the tests carried out with the apparatus (1) is to deduce, through the domains of frequency and time Rmssd, and adipometry, the presence of a central glucocorticoid resistance, a condition to be inferred in the case in which the VLFs are low (lack of neuroendrocrine activation due to central resistance and presumable connected thyroid deficits, from the "clock" function of the same gland), while the values of the sympathetic are high, a condition perpetuated in the measurements day after day.

This leads to the conclusion that the biofeedback system is altered, that there is a presence of white visceral adipose, emitter of inflammatory cytokines with low, almost no energy activity of the mitochondria.

The exchange with the medical figure responsible for the client/patient is necessary, in order to direct analysis and subsequent therapeutic processes and above all the movement, which could presumably worsen an emerging condition of cellular dysregulation on an anaerobic basis.

Specifically, a mode of cross-check on the induction of the case, can be carried out by making Buteyko respiratory activity, checking if the VLFs have a peak in the next measurement, clearly additable to a positive response in acute of the process amygdala- hippocampus-axis HPA); a condition for which operational choices can be made, timed on the basis of clinical data, concerning the reintroduction of movement as the keystone in an embodied optimisation (movement reactivates the mitochondria, with anti-ox properties, releases BDNF, michins and osteocrin, chemical mediators of brain well being).

When this happens, it can presumably confirm the correctness of the previously assumed assessment.

This freezing condition, with more or less repeated or permanent transitions, leads over time to the depletion and ineffectiveness of the immune system, suppressing it and paving the way for the increasingly common autoimmune diseases, dermatitis, Chron’s, celiac disease.

At this juncture, a possible presence of pituitary hyperactivation in the emission of neurotransmitters and hormones aimed at bringing the body back into sectoral homeostasis and systemic allostasis is sensed, deduced and measured, in other words: if the person has hypersecretion of glucocorticoids.

This data detected by the heart rate variation detector (HRV) and the capnograph (CAP) is compared directly with the adipometer (ADI) (e.g. a Hosand adipometer), which precisely detects the level of hormonal adiposity.

In practice, if an altered state of SAT "superficial adipose tissue" is detected, there is direct confirmation of chronic cortisolemic hyperactivation by adrenal ACTH, with loss of morning urination, defecation disorders (stools with water, which is not reabsorbed in the colon given the stress and inflammatory state).

The CO2 appears normal, indeed it often rises in values, around the sufficient 36 mm/hg. This happens because the upper hand of the dorsal vagus DMNX creates the conditions for a complete dissociation from the environment and a progressive levelling down of the vital levels. A pioneer in this physiological condition is sleep apnoea.

To summarise the functioning of the apparatus (1) it can be stated that it provides for:

A) Detecting the oscillatory frequencies of dynamic walking rhythms defined as "Forward Locomotor Movement" by means of an isoinertial sensor (e.g. of the type marketed by the Sensor Medica company), from which the oscillatory frequency of the individual's Centre of Mass is obtained. The sensor emits data from which an algorithm is used to determine the optimal frequency of Forward Locomotor Movement. The sensor should be positioned at the lateral femoral condyle, alternating with both legs.

B) Optionally detect the static rhythm oscillators of the neck. In this case we focus on the oscillatory properties of the mentioned arthromuscular district: the neck for its anatomo- functional characteristics - which is called "kinesthetic rachid oscillator", is an excellent detector of inability and osteoarticular dysfunction in oscillation during movement. The degrees of left and right rotation of C2 with locked vertebrae C3 to C7 are measured, through anterior skull flexion performed by the practitioner.

The neck (vertebrae Cl to Cl) connects the two "cranial vertebrae" occiput sphenoid, to the vertebral column, which from T1 onwards assumes the classic scolioses, which are functional to pass oscillatory force lines of gait.

With the LEG RAISE test it is possible to check the quality of the kinaesthetic oscillators, which are part of the peripheral nervous system, the "somatic" part.

To measure the autonomic part of the Peripheral Nervous System, we use a HRV heart rate variability detector, for example of the type marketed by the company Hosand. With this detection, through the algorithm that will be created to compare the data acquired from the domains of time of Rmssd and frequency VLF - HF - LF, in order very low frequency, high frequency and low frequency, are able to read (even without algorithm), the emotional state and autonomic nervous activation of the subject, that is, how he is placed in the environment.

It is possible to identify with absolute certainty whether the subject is in a state of sympathetic hyperactivation, whether in dissociation of the body and mind from the environment, whether in a state of 'freezing', whether momentary or recurrent, whether Light or Over.

This is possible thanks to the comparison with the data collected by the capnograph (e.g. Maximo type), which provides data of endogenous CO 2 pressure and respiratory acts per minute.

When LFs are high and HFs are low, with a high VLF input we are in the presence of light freezing - dissociation with fear or without fear, confirmed by capnography with high ventilatory acts and low endogenous CO 2 levels.

When HF and LF are low, tending towards zero, and VLFs are high, we are in the presence of over freezing, confirmed by capnography (i.e. by the maximum apnoea value entered, for example, manually) with normal, almost low respiratory acts and normal CO 2 , tending to rise.

HRVs provide a history of the subject, capnography an immediate emotional state. These data are used to deduce whether the Over Freezing is temporary and with the possibility of a quick "exit" (the history of Rmssd is very important) or lasting and therefore worthy of more attention.

These are called cardio-pulmonary oscillators and are related to Porges’ polyvagal theory implemented by concepts of biochemical oxygen-carbon dioxide exchange.

The Peripheral Nervous System part can be compared by interfacing with a hair analyser (SDR), e.g. of the S-Drive type from Epinutracell. This device, which uses oscillatory concepts to resonate the data “embedded” in the subject's hair, gives a very detailed and accurate picture of the biological epigenetic oscillator.

Epinutracell's S-drive provides the biological state of each body system.

Varying and synchronising the autonomic and somatic oscillators will lead to better biological data from the S-drive.

In conclusion, this apparatus (1) can provide:

- the detection by the cardiopulmonary oscillators (HRV) of the variability of the heart rate and, optionally, the detection by a capnograph (CAP) or by manually entered data (MI) related to the maximum apnoea, (CAP), to provide an evaluation related to the autonomic nervous system (I);

- detection by means of the isoinertial sensor (SEN) for somatic nervous system (II) assessments;

- comparison by means of reference data; - the comparison with the values of adipometer (ADI) and bioimpedance meter (BIA) to provide in output a series of values that can be, for example:

- (VI), i.e. "green light": data in the normal range, synchronised, for movement activity, adequately positive emotional state.

- (V2), i.e. "red light": movement or cardio-pulmonary data not in the norm, absolutely not synchronised, recovery of the autonomic system not completed: prescribed Stop.

- (V3), i.e. "yellow light": data not completely synchronised, light freezing, movement possible according to a predefined method and mental coaching.

- (V4), or "orange light": dissociated state, prolonged Over Freezing in progress, urgent adaptation of exercises and therapist session.

In addition, from the test carried out by the hair analyser (SDR), the output signal may involve dietary advice from a nutritional biologist.

The proposed examples are not to be considered in a limiting sense since the method implemented by the apparatus in question allows to operate on all variables, i.e. to intervene in all the above-mentioned conditions of “frrezing with fear”, “freezing without fear”, “temporary over freezing”, “over freezing”.

As indicated above, the present invention relates to an apparatus (1) and a related method for measuring physiological parameters.

The method in question is therefore usable for measuring physiological parameters and determining, through the combination of measured values and comparison of these values with reference values, the general state of health of an individual in its complexity, or, as for the apparatus, for obtaining a general value which takes into account the interactions between the autonomic peripheral nervous system and the somatic peripheral nervous system.

The method is characterised in that it comprises the following steps:

- detecting the heart rate variability linked to the individual under examination by means of a heart rate variability detector (HRV);

- detecting a movement value using an isoinertial sensor (SEN) comprising a movement sensor positioned at the height of the lumbar region of the individual under test;

- use a central unit (CU) connected in input to said heart rate variability detector (HRV) and to said isoinertial sensor (SEN) and provided with a software (ALG) able to provide in output a value (VI, V2, V3, V4) corresponding to the combined evaluation of the input data and in which the data provided by the heart rate variability detector (HRV) are correlated to the evaluation of the state of the peripheral autonomic nervous system and the data provided by the isoinertial sensor (SEN) are correlated to the evaluation of the state of the somatic peripheral nervous system.

The positioning of the sensor at the height of the lumbar region of the individual under examination was found to be extremely effective in providing significant results during all the experiments carried out.

Advantageously, the method involves the central unit (CU) using frequency data. In particular, the central unit (CU) can use frequency values provided by the heart rate variability (HRV) detector and frequency values provided by the isoinertial sensor (SEN). The software (ALG) that enables the implementation of this method is designed to process the data received as input from the central unit (CU) and is set up to consider the following readings as normal:

- for the heart rate variability (HRV) detector: VLF value of approximately 23 (± 5)%, LF value of approximately 25 (± 5)%, HF value of approximately 51 (± 5)%, with an rMSSD value between 40 (± 5) and 60 (± 5); - for the capnograph (CAP), if any, a CO2 mmHg value > 36 mmHg;

- for the “maximum apnoea” value, if any, a value greater than 40 seconds.

Naturally, the invention is not limited to what has been described and illustrated, but can be widely varied as regards the arrangement, shape and nature of the components used without thereby abandoning the inventive teaching described above and claimed hereinafter.