CN112587157A

CN112587157A - Noninvasive intraoral genioglossus myoelectrical activity assessment method and system

Info

Publication number: CN112587157A
Application number: CN202011463244.5A
Authority: CN
Inventors: 叶京英; 周颖倩
Original assignee: Beijing Tsinghua Changgeng Hospital
Current assignee: Tsinghua University; Beijing Tsinghua Changgeng Hospital
Priority date: 2020-12-14
Filing date: 2020-12-14
Publication date: 2021-04-02
Anticipated expiration: 2040-12-14
Also published as: CN112587157B

Abstract

The invention discloses a noninvasive intraoral genioglossus myoelectrical activity assessment method, which comprises the following steps: s1, acquiring AHI index of the subject; s2, acquiring ggEMG signal parameter values and Pepi signal parameter values for subjects with AHI > 15: s3, respectively calculating a unit pressure myoelectric value R1 in the waking period, a unit pressure myoelectric value R2 in the early stage of falling asleep, a minimum unit pressure myoelectric value R3 in the N2 period of apnea, a maximum unit pressure myoelectric value R4 in the N2 period of apnea and a unit pressure myoelectric value R5 after the nasopharyngeal airway is placed in the N2 period according to the ggEMG signal parameter value and the Pepi signal parameter value, and calculating the mean value and the R standard deviation of R1-R5; s4, according to the AHI index and the R standard deviation, the electromyographic activity of the intra-oral genioglossus muscle of the subject with the AHI of more than 15 is classified, and the functional factors related to the genioglossus muscle of the severe subject in OSA with the AHI of more than 15 can be objectively evaluated in a targeted manner, so that objective basis is provided for treatment of the cause. The invention also discloses a system for realizing the evaluation method.

Description

Noninvasive intraoral genioglossus myoelectrical activity assessment method and system

Technical Field

The invention relates to a noninvasive intraoral genioglossus myoelectrical activity assessment method, and also relates to a system for realizing the noninvasive intraoral genioglossus myoelectrical activity assessment method.

Background

Obstructive Sleep Apnea (OSA) is a common sleep disordered breathing disease, and can cause a series of pathophysiological changes such as night hypoxia, hypercapnia, significant fluctuation of intrathoracic pressure, sleep disorder and the like. Numerous studies have demonstrated that OSA is an independent risk factor for many chronic diseases such as hypertension, coronary heart disease, cerebrovascular disease, diabetes, etc. Moreover, OSA is a high-risk factor that can cause traffic accidents, and seriously threatens the life safety of the driver of the vehicle. There is currently a lack of simple and effective treatments for OSA. The american society for sleep has evaluated the current clinical practice of treatment as follows: the cure rate of Continuous Positive Airway Pressure (CPAP) is 90%, but the subject has poor long-term wearing compliance; the cure rate of uvula palatopharynoplasty (UPPP) is only 50% -60%; the cure rate of the oral appliance is only 50-60%. The fundamental reasons for the limited efficacy of OSA are the lack of insight into the pathophysiological mechanisms of OSA and the incompetence of the efficacy evaluation system.

Currently, an increasing number of studies have demonstrated that OSA is a disease associated with multiple etiologies. In addition to the mechanism of anatomical narrowing of the upper airway, functional factors involved in the regulation of the neuro-upper airway dilator muscles play a non-negligible role. The genioglossus muscle is used as a main upper airway dilator and an effector for receiving respiratory-neural regulation output signals, and has the function of directly resisting upper airway resistance to maintain the patency of the upper airway. Studies have shown that the functional activity of the genioglossus muscle varies from one OSA subject to another, with macroscopic manifestations of activity dysregulation that may appear to varying degrees after stimulation by inspiratory negative pressure. The scholars suggested that 2/3 degrees of severity of the disease in subjects with OSA may be related to neuro-upper airway dilator regulatory function, 1/3 and airway anatomical burden. However, the current clinical evaluation of functional factors associated with neuro-upper airway dilator modulation has been of little use, which may be one of the reasons for the limited efficacy of current OSA. Especially for invasive treatment means such as surgical operation, preoperative evaluation on nerve-upper airway dilator muscle of OSA subjects is beneficial to excluding subjects which are not suitable for operation and are dominated by non-anatomical factors, so that the curative effect is improved.

Disclosure of Invention

The invention aims to solve the primary technical problem of providing a noninvasive method for evaluating electromyographic activity of intraoral genioglossus muscle.

The invention aims to solve another technical problem of providing a noninvasive intraoral genioglossus myoelectrical activity assessment system.

In order to achieve the technical purpose, the invention adopts the following technical scheme:

according to a first aspect of embodiments of the present invention, there is provided a non-invasive intraoral genioglossus myoelectrical activity assessment method, comprising the steps of:

s1, calculating the AHI index of the subject according to the overnight polysomnography data;

s2, aiming at the testee with AHI more than 15, acquiring the following parameters under the condition of intra-oral surface myoelectricity synchronous intra-cavity negative pressure monitoring; respectively acquiring a genioglossus myoelectric (ggEMG) signal parameter value and a parameter value of an epiglottis horizontal airway pharyngeal cavity pressure (Pepi) signal according to 4 stages of resting respiration in a waking period, resting respiration in an early stage of falling asleep, obstructive apnea time period in an N2 sleeping period and resting respiration after a nasopharyngeal airway is placed in an N2 sleeping period;

s3, respectively calculating a unit pressure myoelectric value R1 in the waking period, a unit pressure myoelectric value R2 in the early stage of falling asleep, a minimum unit pressure myoelectric value R3 in the apnea in the N2 period, a maximum unit pressure myoelectric value R4 in the apnea in the N2 period and a unit pressure myoelectric value R5 after the nasopharynx airway is placed in the N2 period according to the parameter value of the ggEMG signal and the parameter value of the Pepi signal, and calculating the mean value and the R standard deviation of the R1-R5 values;

s4, according to the AHI index and the R standard deviation, the electromyographic activity of the intraoral genioglossus of the subject with the AHI of more than 15 is classified.

Preferably, in step S4, when the AHI is greater than 15 and the R standard deviation is greater than or equal to 10, the subject is judged to be in compliance with the diagnosis of moderate-severe OSA, the genioglossus muscle has sufficient functional activity, and the disease factor is mainly anatomical stenosis; when AHI is more than 15 and R standard deviation is less than 10, judging that the subject accords with the diagnosis of moderate-severe OSA, the genioglossus muscle functional activity is poor, the posterior area of the tongue is easy to collapse, and the disease factors are comprehensive.

Preferably, in step S2, the acquired parameter values of the genioglossus muscle electromyography signal include: a maximum myoelectric value, a peak myoelectric value, an apnea minimum myoelectric value, and an apnea maximum myoelectric value.

Preferably, in step S1, all myoelectric original amplitude signals are converted into Root Mean Square (RMS) values to measure the activation degree of myoelectric.

Preferably, in step S2, the parameter values of the acquired epiglottis horizontal airway pharyngeal cavity pressure signal include: a calm breath Pepi value, an apnea Pepi minimum value, an apnea Pepi maximum value.

Preferably, in the step S3, the waking period unit pressure myoelectric value R1 is the waking period peak myoelectric value/waking calm breath Pepi value; the myoelectric value R2 of the unit pressure at the early stage of falling asleep is the peak myoelectric value at the early stage of falling asleep/the Pepi value of the quiet breath at the early stage of falling asleep; the apnea minimum unit pressure myoelectric value R3 at N2 is the apnea minimum myoelectric value/apnea Pepi minimum; the apnea maximum unit pressure myoelectric value R4 at N2 is the apnea maximum myoelectric value/apnea Pepi maximum; the unit pressure myoelectric value R5 after the nasopharyngeal airway in the N2 period is equal to the peak myoelectric value after the nasopharyngeal airway in the N2 period is placed/the calm breath Pepi value after the nasopharyngeal airway in the N2 period is placed.

According to a second aspect of the embodiment of the invention, a noninvasive intraoral genioglossus myoelectrical activity evaluation system is provided, which is used for realizing the noninvasive intraoral genioglossus myoelectrical activity evaluation method and comprises an AHI index acquisition module, a ggEMG signal acquisition module, a Pepi signal acquisition module and a data processing module;

the AHI index acquisition module is used for acquiring the AHI index of the subject from overnight polysomnography data;

the ggEMG signal acquisition module is used for acquiring ggEMG signal parameter values of 4 stages of calm breathing of a subject in a waking period, calm breathing in an initial stage of falling asleep, obstructive apnea time period in an N2 sleep period and calm breathing after a nasopharynx airway is placed in an N2 sleep period;

the Pepi signal acquisition module is used for obtaining Pepi signal parameter values of 4 stages of quiet respiration of a subject in a waking period, quiet respiration in an early stage of falling asleep, obstructive apnea time period in an N2 sleep period and quiet respiration after a nasopharyngeal airway is placed in an N2 sleep period;

the data processing module is used for respectively calculating a unit pressure myoelectric value R1 in the waking period, a unit pressure myoelectric value R2 in the early stage of falling asleep, a minimum unit pressure myoelectric value R3 in the apnea in the N2 period, a maximum unit pressure myoelectric value R4 in the apnea in the N2 period and a unit pressure myoelectric value R5 after the nasopharyngeal airway in the N2 period is placed according to the parameter values of the ggEMG signal and the parameter values of the Pepi signal, solving the mean value and the R standard deviation of the R1-R5 values, and then typing the electromyographic activity of the intraoral genioglossus muscle of the subject with AHI >15 according to two parameters of the AHI index and the R standard deviation.

Preferably, the ggEMG signal acquisition module acquires ggEMG signals through a non-invasive intraoral surface electromyographic signal acquisition device;

the Pepi signal acquisition module acquires a Pepi signal through an esophageal pressure measuring instrument;

the noninvasive intraoral surface electromyographic signal acquisition equipment and the esophageal pressure measuring instrument are connected with polysomnography monitoring equipment.

Preferably, the noninvasive intraoral surface electromyographic signal acquisition equipment comprises a lower mandible tooth transparent holder and two silver chloride spherical electrodes, wherein the lower mandible tooth transparent holder is manufactured according to the oral floor of a testee and a lower mandible tooth system, and the two silver chloride spherical electrodes are embedded on the inner side surface of the lower mandible tooth transparent holder and positioned between canine teeth on two sides and the lingual side of premolar teeth by using self-setting plastics.

Preferably, the polysomnography equipment is used for acquiring electroencephalogram signals, nasal airflow signals, thoracoabdominal respiratory motion signals and oxyhemoglobin saturation signals simultaneously.

The noninvasive evaluation method for electromyographic activity of the intraoral genioglossus muscle provided by the invention is used for inducing an intraoral surface electromyographic synchronization intracavity negative pressure monitoring technology under sleep, establishing a noninvasive intraoral genioglossus muscle electromyographic activity evaluation system of an OSA subject based on an Apnea-Hypopnea Index (AHI) and a specific pressure electromyographic value (Ratio of peak phasic ggEMG to Pepi, Rgg), and being capable of typing the OSA moderate-severe subject with the AHI greater than 15, thereby objectively evaluating functional factors related to the genioglossus muscle of the OSA moderate-severe subject with the AHI greater than 15 in a targeted manner and being beneficial to providing objective basis for the treatment of factors.

Drawings

FIG. 1 is a flow chart of a non-invasive intraoral genioglossus myoelectrical activity typing assessment method;

FIG. 2 is ggEMG, P during calm breathing_epiA parameter definition schema;

FIG. 3 is a ggEMG, P during apnea_epiA parameter definition schema;

FIG. 4 is a schematic view of the location of a piezometer probe during induced sleep;

FIG. 5 is a technical roadmap for a non-invasive intra-oral genioglossus myoelectrical activity typing assessment system;

fig. 6A is a trend-over-trend line graph of peak ggEMG;

FIG. 6B is a trend line graph of Pepi;

FIG. 7 is a block diagram of the components of a non-invasive intraoral genioglossus myoelectrical activity typing assessment system.

Detailed Description

The technical solution of the present invention is further described in detail with reference to the accompanying drawings and specific embodiments.

The application provides a noninvasive intraoral genioglossus myoelectricity activity assessment method, which can be used for analyzing and summarizing individualized differences of genioglossus electromyography (ggEMG) activities of different OSA subjects in a targeted manner by means of a noninvasive intraoral genioglossus myoelectricity monitoring technology, so as to finish genioglossus activity assessment typing of different OSA subjects.

As shown in fig. 1, the non-invasive intraoral genioglossus myoelectrical activity assessment method provided by the invention comprises the following steps:

s1, obtaining a subject Apnea Hypnea Index (AHI) from the sleep monitoring data;

s2, aiming at the testee with AHI more than 15, acquiring the following parameters under the condition of intra-oral surface myoelectricity synchronous intra-cavity negative pressure monitoring; respectively acquiring a genioglossus myoelectric (ggEMG) signal parameter value and a parameter value of an epiglottis horizontal airway pharyngeal cavity pressure (Pepi) signal aiming at 4 stages of resting respiration in a waking period, resting respiration in an early stage of falling asleep, obstructive apnea time period in an N2 sleeping period and resting respiration after a nasopharyngeal airway is placed in an N2 sleeping period;

s4, according to the AHI and the R standard deviation, the electromyographic activity of the intraoral genioglossus of the subject with the AHI of more than 15 is typed.

The following describes specific steps of a noninvasive method for evaluating electromyographic activity of the genioglossus muscle in the mouth.

subjects underwent overnight regular Polysomnography (PSG) and synchronized intraoral ggEMG monitoring. The calculation of the AHI parameters of the subject from overnight polysomnography data is conventional and will not be described herein.

According to the current diagnosis standard, the OSM grade of the subject can be preliminarily determined according to the overnight PSG monitoring data, wherein, the AHI is less than 5 times/hour, and the OSA diagnosis is not met; AHI is more than or equal to 5 and less than 15 times/hour, which is in line with mild OSA diagnosis; AHI is more than or equal to 15 and less than 30 times/hour, which is in accordance with moderate OSA diagnosis; AHI is more than or equal to 30 times/hour, which is in accordance with severe OSA.

The OSA subject suffers from chronic snoring for a long time, which predisposes the upper airway tissues to mechanical damage caused by pharyngeal negative pressure oscillations and strong muscle contractions generated by the opposing airway closure, which can cause nerve and muscle fiber structure destruction and inflammatory reactions of the pharyngeal tissues, resulting in upper airway dilator muscle contraction dysfunction and muscle weakness, which can be particularly reflected in the genioglossus muscle. Neuromuscular injury of the genioglossus muscle can directly affect the reflex expansion capacity of the upper airway, further leading to increased collapse of the upper airway and formation of a vicious circle. Thus, the severity of injury to the genioglossus muscle in an OSA subject is related to the length of the subject's disease course and also to the severity of the subject's disease.

Although AHI is currently used to classify the severity of OSA disease, the assessment of the grading of upper airway dilator muscles in OSA subjects cannot be completely dependent on the classification of AHI. The correlation analysis of the AHI of OSA subjects with different ggEMG-Pepi variation degrees by the applicant finds that the subjects have great difference in the correlation analysis of the AHI. The respiratory events of the subjects with small variant ggEMG-Pepi mainly relate to the anatomical and waking-sleeping electromyographic activity change values. The respiratory events of the subjects with larger variation of the ggEMG-Pepi are mainly related to functional factors. The choice of surgical mode and the therapeutic effect may differ between the two.

Therefore, the noninvasive intraoral genioglossus myoelectric activity assessment method provided by the invention is used for performing induced sleep fiber laryngoscope examination (DISE) examination on the screened moderate-severe OSA subjects (AHI is more than or equal to 15), synchronously performing ggEMG monitoring and upper airway intracavity pressure monitoring, and performing intraoral ggEMG activity rating according to the obtained parameters, and has high safety and applicability. The activity conditions of the upper airway dilator muscles of different OSA subjects can be noninvasively and accurately divided, and the phenotypic classification of the OSA diseases is favorably refined, so that individualized treatment schemes are formulated for different types of OSA subjects.

S2, aiming at the AHI 15 testee, the parameter acquisition method under the monitoring of the negative pressure in the oral surface myoelectricity synchronous cavity comprises the following steps:

the applied noninvasive intraoral surface electromyographic signal acquisition device (see the record in the Chinese utility model patent ZL201520088053.3) can stably acquire signals mainly based on genioglossus myoelectricity (ggEMG). An oesophagometer (Gaeltec, UK) was used to collect epiglottis level airway pharyngeal cavity pressure (Pepi). The noninvasive intraoral surface electromyographic signal acquisition equipment and the esophageal pressure measuring instrument can be connected to any polysomnography equipment and synchronously record and analyze electroencephalogram signals, nasal airflow signals, thoracoabdominal respiratory motion signals, oxyhemoglobin saturation signals and the like. The collected myoelectric and pressure raw signals can be introduced into analysis software (Spike 2 software of CED company in UK) for signal processing and measurement.

(1) Acquiring parameter values of the ggEMG signals:

all myoelectricity original amplitude signals need to be converted into root mean square values (RMS) to measure the activation degree of myoelectricity, and the conversion formula of the root mean square amplitude values (RMS) is as follows:

under the condition of inducing sleep, the measurement of the electromyographic parameter value of each monitored object needs to comprise the following 4 time intervals: quiet breathing in the waking period, quiet breathing in the early period of falling asleep, obstructive apnea time period in the N2 sleep period, and quiet breathing after the nasopharynx airway is placed in the N2 sleep period. The measurement of the signals during the quiet breathing period (including the waking period, the early sleep period and the N2 sleeping period after the nasopharyngeal airway is placed) takes at least 5 consecutive respiratory cycles for analysis and then takes the average value as the final data record. The signal during the N2 sleep obstructive apnea period was measured by taking the average of at least 5 corresponding events analyzed as the final data record.

The values of the ggEMG parameters to be included in the calculation include:

(ii) maximum myoelectric value (Maximal ggEMG, ggemmax): the maximum RMS amplitude value when the subject forcibly stretches the tongue or the tongue butts against the tongue surface of the maxillary anterior incisor is corrected by dividing all parameter values by the value;

peak phasic ggEMG (Peak phasic ggEMG): during the quiet respiration, the maximum value of the inspiratory RMS amplitude is divided by the ggEMG Max, and the numerical unit is defined as% Max, which can reflect the myoelectric activation degree of the genioglossus muscle under the stimulation of the self inspiratory negative pressure during the quiet respiration of the subject.

③ apnea Minimum myoelectric value (Minimum ggEMG reducing apnea): the minimum value of RMS amplitude of 1/2 segments before the obstructive apnea event in the sleep period of N2 is divided by ggEMGMmax, and the numerical unit is defined as% Max, which can reflect the activation degree of the genioglossus muscle myoelectricity of the subject in the early period of apnea.

(iv) apnea maximum myoelectric value (Peak ggEMG after apnea): the maximum value of the RMS amplitude corresponding to the first respiratory cycle after the end of the obstructive apnea event in the sleep period of N2 is divided by ggEMGMmax, the numerical unit is defined as% Max, and the value can reflect the activation degree of the genioglossus muscle myoelectricity of the end stage of the apnea of the subject.

(2) Parameter value acquisition of the Pepi signal:

each monitoring subject fixes the probe of the pressure sensor at the epiglottic margin level under the guidance of an electronic laryngoscope (the position of the piezometric tube probe during the induction of sleep is shown in figure 4), and orders the subject to breathe quietly and zero at the end of expiration.

The period of selecting Pepi parameter values needs to be synchronous and corresponding to the ggEMG, and the parameter values need to be included in the calculation comprise:

first, calm breath Pepi value: the absolute value of the maximum value of the negative pressure at the end of inspiration corresponding to the period of calm respiration, and the numerical unit mmHg can reflect the maximum level of the negative pressure of inspiration generated by the subject during the period of calm respiration.

② Apnea Pepi min (N2 Apnea minium Pepi): the absolute value of the minimum end-of-inspiration negative pressure value corresponding to segment 1/2 prior to the obstructive apnea event, in units of mmHg, may reflect the level of intraluminal negative pressure at the beginning of the subject's apnea.

③ apneic Pepi maximum (N2 Apnea Maximal Pepi): the absolute value, in units of mmHg, corresponding to the maximum end-inspiratory negative pressure value during the first respiratory cycle after the end of an obstructive apnea event may reflect the intraluminal negative pressure level at the end of the subject's apnea.

Fig. 2 shows a diagram of ggEMG, Pepi parameter definition during quiet breathing, where NP is nasal airflow pressure; THO ═ chest movement; pepi ═ epiglottic horizontal luminal pressure; EMGraw is the original intraoral genioglossus myoelectric signal; RMS is the root mean square signal of the EMGraw amplitude.

Fig. 3 shows a diagram of ggEMG, Pepi parameter definition at apnea, where NP is nasal airflow pressure; THO ═ chest movement; pepi ═ epiglottic horizontal luminal pressure; EMGraw is the original intraoral genioglossus myoelectric signal; RMS is the root mean square signal of the EMGraw amplitude.

S3, according to the parameter value of the ggEMG signal and the parameter value of the Pepi signal, the calculating method of the muscle electrical value (RggEMG) of unit pressure is as follows:

the unit pressure myoelectric value (RggEMG) objectively reflects the negative pressure resistance functional activity of the genioglossus muscle of an individual under the pressure in a unit cavity, and the higher the RggEMG value is, the stronger the pressure change resistance of the genioglossus muscle is, and the stronger the regulating capacity of the genioglossus muscle for maintaining the airway patency is. The muscle electrical value per unit pressure (rggmg) ═ peak value ggEMG/Pepi, defined as a numerical unit% Max.

The corresponding rggmg is calculated for the 4 periods (the waking period calm breathing, the falling asleep initial calm breathing, the N2 sleep period obstructive apnea time period, and the N2 sleep period nasopharynx airway postcalming breathing), and the obtained values are respectively denoted as R1 (the waking period rggmg), R2 (the falling asleep initial rggmg), R3 (the N2 period apnea minimum value rggmg), R4 (the N2 period apnea maximum value rggmg), and R5 (the N2 period nasopharynx airway postrhgmg) (see table 1 in summary).

Then, the mean of the values of R1 to R5 was obtained for each subject, and the standard deviation, namely R standard deviation, was calculated. The index of the R standard deviation can objectively reflect the dispersion degree of the genioglossus muscle functional activity data of a subject from waking, falling asleep to respiratory events and eliminating the respiratory events in the whole process, and comprehensively evaluate the comprehensive activity of the genioglossus muscle in different states.

After a large number of data analysis of OSA subjects, it is proved that the R standard deviation is closely related to an Apnea Hypopnea Index (AHI), a minimum blood oxygen saturation and the like in a polysomnography result, the efficacy of reflecting the disease severity of the subjects is achieved, and objective evaluation is conducted on functional factors related to the genioglossus muscle of the OSA subjects in a targeted mode. The less standard deviation R, the less powerful the activity of the genioglossus muscle in OSA subjects, the more pronounced the tendency of the retrolingual airway to collapse, and the more severe the extent of the disease. For this group of subjects, the functional assessment of genioglossus activity should be particularly appreciated, and treatment should be actively applied to avoid the limitation of efficacy due to improper treatment regimen.

TABLE 1 summary of different State RggEMG parameters

S4 establishment of noninvasive intraoral genioglossus myoelectric activity typing evaluation system

The establishment of the typing evaluation system mainly refers to two parameters of AHI and R standard deviation, and is mainly used for objectively evaluating the functional activity of the genioglossus muscle of a subject and guiding the selection of a treatment scheme (see Table 2) by referring to the electromyographic characteristics of normal people and OSA subjects and the feasibility of clinical application.

TABLE 2 noninvasive evaluation criteria for electromyographic activity of intraoral genioglossus muscle

Note: OSA: obstructive sleep apnea; AHI: apnea hypopnea index; REM: a snap eye sleep period; NREM: non-snap eye sleep periods; ggEMG: electrical values of genioglossus muscles; pepi: horizontal pharyngeal cavity pressure of epiglottis

Further refinement of the moderate-severe OSA subjects was possible by combining the R standard deviation calculated at step S3 with the AHI index calculated at step S1. When the AHI is more than 15 and the R standard deviation is more than or equal to 10, judging that the test subject accords with the diagnosis of moderate-severe OSA, the genioglossus muscle functional activity is still enough, and the disease factor is mainly anatomical stenosis; when AHI is more than 15 and R standard deviation is less than 10, judging that the subject accords with the diagnosis of moderate-severe OSA, the genioglossus muscle functional activity is poor, the posterior area of the tongue is easy to collapse, and the disease factors are comprehensive. According to the judgment result, different treatment schemes can be designed.

In order to better explain the method for non-invasive assessment of electromyographic activity of the intraoral genioglossus muscle provided by the present invention, the present invention is described in detail below with reference to the technical scheme shown in fig. 5.

Firstly, according to the diagnosis standard of 'adult obstructive sleep apnea multidisciplinary diagnosis and treatment guidelines' issued in 2018 domestically, subjects who are primarily referred to as sleep snoring and daytime sleepiness in the initial diagnosis are subjected to sleep monitoring examination, and then subjects with moderate or more than moderate OSA are screened according to AHI. Then, referring to the treatment intention of the subject, particularly for the subject who tends to be treated by the palatopharyngeal operation, the drug-induced sleep fiber endoscopy (DISE) is further improved, and negative pressure monitoring in the oral surface myoelectricity synchronous cavity is carried out in the process of the examination at the same time to acquire data related to the myoelectricity function of the genioglossus muscle.

The specific process is as follows: each subject should wear a sleep monitoring device (leads at least including brain electricity, nasal airflow, chest and abdomen movement, and blood oxygen saturation) and an intra-oral surface myoelectricity monitoring device before checking. The subjects were asked to maintain the supine position and to force the tongue against the anterior maxillary incisors for about 10 seconds, and the maximum myoelectric values obtained were repeated 3 times in succession. And then, after the surface anesthesia of the nasal cavities at both sides of the subject is carried out by using a 1% tetracaine solution, the piezometric tube is placed into the pharyngeal cavity from the nasal cavity under the guidance of an electronic laryngoscope, and the position of the piezometric tube is fixed when the pressure probe reaches the level of the upper edge of the epiglottis. The subject is instructed to breathe smoothly, the fluctuation of the pressure value on the measuring instrument is observed, and zero setting is carried out at the end of expiration. Dexmedetomidine hydrochloride was given by the anesthesiologist to induce sleep. The observation time is that subjectively the subject falls asleep, the oral stimulus does not respond, and the stimulus such as pain can be aroused until brain waves show typical sleep waveforms such as spindle waves and the like in the period N2, which proves the success of inducing sleep. The sleep time of the stable N2 needs to be ensured for at least 10 minutes under DISE, the change of airway collapse form during respiratory events is comprehensively observed, and the sufficient collection of myoelectric and intracavity pressure data is ensured. After completing the monitoring of sleep for more than 10 minutes in stage N2 under the disc, the nasopharyngeal airway was inserted from the nasal cavity of the subject to relieve the obstruction state of the upper airway of the subject, and the data under sleep for more than 10 minutes in stage N2 was recorded under this state. The R standard deviation value is then derived according to the algorithm above. The assessment of the functional activity of the genioglossus muscle before surgery is finally completed according to the further divisions that the R standard deviation is less than 10 and more than or equal to 10. Finally, according to the typing result, the clinician is guided to select an appropriate treatment scheme.

Finally, supplementary introduction is provided for the establishment process of the non-invasive intraoral genioglossus myoelectrical activity evaluation system shown in table 2 used in the non-invasive intraoral genioglossus myoelectrical activity evaluation method provided by the present invention.

First, all subjects underwent overnight regular Polysomnography (PSG) and synchronized intraoral ggEMG monitoring. Then, according to the diagnostic criteria, the control group (AHI <5 times/hour), the mild group (AHI <15 times/hour), the moderate group (AHI <15 times/hour) and the severe group (AHI > 30 times/hour) can be clearly distinguished according to the sleep Apnea Hypopnea Index (AHI Index, which is the number of times of Apnea and Hypopnea events occurring per hour in the overnight PSG monitoring data. And (3) carrying out induced sleep fiber laryngoscope examination (DISE) on the screened moderate-severe OSA subjects (AHI is more than or equal to 15), synchronously carrying out ggEMG monitoring and upper airway intracavity pressure monitoring, and carrying out intraoral ggEMG activity rating according to the obtained parameters.

Sleep induction fiber laryngoscope examination process

After measurement of airway structure during the waking period, the sleep state was induced by the anesthesiologist by administration of dexmedetomidine hydrochloride. Dexmedetomidine hydrochloride has been reported to induce brain wave activity approximating that of sleep at stage N2, has little effect on respiratory center, and is currently used in examination procedures for simulating sleep. Dexmedetomidine hydrochloride was administered at 0.8mg/kg for 10 minutes, and subjects were observed to adjust to 0.6mg/kg maintenance dose after falling asleep. The observation time is that the subjects are subjectively observed to fall asleep, the oral stimulation is not responded, the stimulation such as pain can be aroused, and typical N2-stage sleep waveforms such as spindle waves generated by brain waves are objectively observed. The subject wears the intraoral surface electrodes to record the synchronized ggEMG signals. The time for stabilizing N2 sleep needs to be ensured for at least 15 minutes under DISE, the change of airway collapse form during respiratory events is comprehensively observed, and the sufficient collection of ggEMG data is ensured. After completing the monitoring of the sleep of the N2 stage for more than 15 minutes under the DISE, the nasal cavity of the subject is placed into the nasopharyngeal airway to relieve the obstruction state of the upper airway of the subject, and the ggEMG, the pressure in the cavity and the change of the airway form under the N2 stage sleep are continuously recorded for more than 15 minutes under the state.

(II) acquisition of ggEMG parameters

The applied noninvasive surface myoelectricity acquisition equipment has been granted utility model patent (ZL201520088053.3), and the device can be synchronously connected on the polysomnography, and myoelectricity activity data can be extracted by the device according to different respiratory states. The device is used for manufacturing a transparent retainer for lower mandible teeth according to the mouth bottom and the lower mandible tooth system of a testee. Two silver chloride ball electrodes (Natus) of 3mm diameter were embedded in the inner side of the fabricated transparent holder of the mandibular teeth with self-setting plastic, positioned between the bilateral cuspids and the lingual side of the premolar teeth, and ensured that the ball electrodes were in contact with the rostral dorsalis muscle prominence and the subject's effort for tongue extension was not restricted. The distance between the two ball electrodes is 10-15mm, and the two ball electrodes are contacted with the genioglossus muscle bulge. The ggEMG signals collected by the bilateral ball electrodes are subjected to discharge and filtration treatment, and the frequency is set to be between 10Hz and 100 Hz.

Values of ggEMG parameters are extracted according to respiratory motion, and the original signal amplitude of the ggEMG is converted into a root mean square value (RMS) through Spike2 software of a CED company in England so as to measure the activation degree of the electromyography. Before monitoring overnight, the examinee was first ordered to maintain the supine position, and the maximum myoelectric value obtained by extending the tongue forcefully against the lingual surface of the anterior maxillary incisors for about 10 seconds, which was repeated 3 times continuously, was defined as the maximum ggEMG value (Maximal ggEMG). All subjects were statistically analyzed as final correction values by dividing the original electromyographic values by their maximum ggEMG values. Myoelectric parameter values included in the analysis were as follows: (1) the minimum value of the expiratory phase ggEMG amplitude is defined as a tension myoelectric value (Tonic ggEMG); (2) the maximum value of the inspiratory phase ggEMG amplitude is defined as a Peak myoelectric value (Peak ggEMG); (3) the mean value of the ggEMG amplitude over a complete respiratory cycle is defined as the mean myoelectric value (Average ggEMG).

According to the values of ggEMG parameters in different cortical states interpreted by the synchronous PSG monitoring data, the value intervals of ggEMG measurement in different cortical states are determined as follows: (1) and (3) value taking in the waking period: the values of the ggEMG parameters in a state of calm breathing in a supine position within 5 minutes; (2) taking values at the early stage of sleep: the values of ggEMG parameters during the first 3 consecutive respiratory movement periods after the subject falls asleep; (3) stable NREM sleep period values: the subject enters a stable N2 period for 5 minutes and then each parameter value of the ggEMG in the supine position is obtained; (4) stable REM sleep period values: the subject enters the ggEMG parameter values in the supine position after the stable REM period; (5) values during obstructive sleep apnea events: when a subject (mainly an OSA subject) is in a supine position in NREM or REM sleep period, selecting a period from nasal catheter airflow disappearance to airflow resumption for ggEMG data measurement according to an obstructive apnea event interpreted by PSG, wherein the ggEMG parameter measurement comprises the following steps: the myoelectric value of the early stage of the event is the minimum value, the myoelectric value of the last stage of the event is the maximum value, and the mean myoelectric value of the apnea period is the maximum value.

The method for calculating the change value of the ggEMG after the conversion of different cortical states comprises the following steps:

(1) wake-sleep-in ggEMG change value (%) (wake-period ggEMG parameter value-sleep-in-early ggEMG parameter value-)/wake-period GGEMG parameter value

(2) ggEMG change value (%) in sleep-NREM period (ggEMG parameter value-N2 period ggEMG parameter value-) in early sleep period/GGEMG parameter value in early sleep period

(3) NREM-REM ggEMG change value (%) - (GGEMG parameter value-REM period ggEMG parameter value at N2 period)/ggEMG parameter value at N2 period

(III) calculation of synergy of upper airway intracavity pressure and ggEMG

We used an esophageal tonometer from Gaeltec, uk to measure the upper airway pharyngeal cavity pressure, and before the line diste, after performing surface anesthesia on the nasal cavities on both sides of the subject with a 1% tetracaine solution, the pressure measuring tube was placed into the pharyngeal cavity from the nasal cavity under the guidance of an electronic laryngoscope, and the position of the pressure measuring tube was fixed when the pressure probe reached the level of the upper border of the epiglottis. The subject is instructed to breathe smoothly, the fluctuation of the pressure value on the measuring instrument is observed, and zero setting is carried out at the end of expiration. And (4) taking out the piezometer tube after DISE monitoring is finished.

Under physiological conditions, in order to maintain airway patency during sleep, the ggEMG activity should not only be directly proportional to the value of the negative pressure in the cavity, but also the trend of the negative pressure in the cavity should be coordinated with the trend of the ggEMG change after being stimulated by the negative pressure, so as to form effective negative pressure reflex activity of the genioglossus muscle for stabilizing the airway. Then, even if the negative intra-cavity pressure and the ggEMG activity are increasing, but the increase degrees of the negative intra-cavity pressure and the ggEMG activity are not matched, the same can be considered as the manifestation of abnormal ggEMG activity. This inability to provide sufficient reflex activity of the genioglossus muscle may be seen as the presence of decompensated performance, and as the presence of genioglossus dysfunction. Studies have shown that there are varying degrees of genioglossus dysfunction in OSA subjects, and that peak ggEMG is the electromyographic component that primarily reflects the activity of the genioglossus as a function of negative pressure within the cavity. In order to evaluate the cooperativity of the ggEMG along with the pressure change, the research uses a ggEMG synchronous Pepi evaluation means under DISE to integrate the whole change trends of Pepi and peak value ggEMG of a testee in the sleep period by 4 states including the initial sleep period, the initial obstructive apnea period (Pepi minimum point) in the N2 period, the terminal obstructive apnea period (Pepi maximum point) in the N2 period and the collapse relief of an airway (after the nasopharyngeal airway is prevented) in the N2 period.

The method for calculating the peak value ggEMG-Pepi variation is shown in table 3, and after the peak value ggEMG-Pepi variations of all the subjects are arranged in an ascending order, the variation trend line graphs of the peak value ggEMG of all the subjects (see fig. 6A) and the variation trend line graphs of the Pepi (see fig. 6B) are referenced, the variation of the peak value ggEMG-Pepi of all the subjects is taken as a dividing point, and all the subjects are divided into a smaller variation group (the variation of the peak value ggEMG-Pepi is less than or equal to 6) and a larger variation group (the variation of the peak value ggEMG-Pepi is greater than 6).

TABLE 3 Peak value ggEMG-Pepi variation calculation

(IV) typing evaluation System

The overnight genioglossus ggEMG activity profile of normal persons compared to OSA subjects of varying severity by analysis of a large body of study data is summarized as follows:

1. in early stages of wakefulness and sleep, the wakefulness ggEMG activity was significantly higher in subjects with mild OSA than in healthy controls. In the sleep calm breathing stage during the non-rapid eye movement (NREM) sleep period, the ggEMG activity of the mild OSA subjects is higher than that of the control group, while all the ggEMG values and variation values during the Rapid Eye Movement (REM) sleep period have no obvious statistical difference, so that the cortical state is supposed to be similar to the normal control for the control transition of the ggEMG activity during the transition from NREM to REM sleep period in the mild OSA subjects.

2. The ggEMG activity in the moderate-severe OSA group was higher at each stage, and peak ggEMG was significantly higher in the early stages of sleep than in the mild OSA subjects, suggesting a trend for enhanced ggEMG activity with increasing disease severity to combat airway narrowing. During the sleep phase, in both NREM and REM phases, the amplitude of the ggEMG activity change was significantly higher in moderate-severe OSA subjects than in mild subjects, although there was no significant difference in the minimal ggEMG during the initial phase of the event. Visible moderate-severe OSA subjects may require greater ggEMG activity during the early stages of sleep to maintain airway stability.

3. According to the method for calculating the variation degree of the peak value ggEMG-P epi, the medium-severe OSA subjects are re-typed, and the group of the ggEMG with the small variation degree of the ggEMG-P epi during the waking period has better compensation capability. In the respiratory event of NREM, the pressure variation of the two groups is the same, the ggEMG-Pepi variation degree is larger than the minimum peak value electromyogram of the small group, and the ggEMG variation range is smaller, so that the attenuation quantity of the ggEMG activity is smaller when the respiratory event occurs in the group with the smaller variation degree, the amplitude of the ggEMG of the group with the larger variation degree is larger when the respiratory event is resisted, the attenuation speed of the ggEMG value is too fast, and the compensation states such as fatigue, pressure reflex imbalance and the like are estimated to be more likely to occur in the genioglossus muscle of the group with the larger variation degree of the ggEMG-Pepi.

Based on the above research results, the noninvasive intraoral genioglossus myoelectrical activity typing standard was summarized as shown in table 2.

As shown in fig. 7, the present invention also provides a system for implementing the above non-invasive method for evaluating electromyographic activity of the genioglossus muscle, including: the system comprises an AHI index acquisition module, a ggEMG signal acquisition module, a Pepi signal acquisition module and a data processing module; the AHI index acquisition module is used for acquiring the AHI index of the subject from overnight polysomnography data; the ggEMG signal acquisition module is used for acquiring ggEMG signal parameter values of 4 stages of calm respiration of a subject in a waking period, calm respiration in an initial sleep period, an obstructive apnea time period in an N2 sleep period and calm respiration after a nasopharynx airway is placed in an N2 sleep period; the Pepi signal acquisition module is used for acquiring Pepi signal parameter values of 4 stages of quiet respiration of a subject in a waking period, the early quiet respiration of falling asleep, an obstructive apnea time period in an N2 sleep period and the quiet respiration after a nasopharyngeal airway is placed in an N2 sleep period; and the data processing module is used for respectively calculating a unit pressure myoelectric value R1 in the waking period, a unit pressure myoelectric value R2 in the early stage of falling asleep, a minimum unit pressure myoelectric value R3 in the apnea in the N2, a maximum unit pressure myoelectric value R4 in the apnea in the N2 and a unit pressure myoelectric value R5 after the nasopharyngeal airway is placed in the N2 according to the parameter values of the ggEMG signal and the parameter values of the Pepi signal, solving the mean value and the R standard deviation of the R1-R5 values, and then typing the electromyographic activity of the intraoral genioglossus muscle of the subject with AHI greater than 15 according to two parameters of the AHI index and the R standard deviation.

Specifically, the ggEMG signal acquisition module acquires ggEMG signals through a non-invasive intraoral surface electromyographic signal acquisition device; the Pepi signal acquisition module acquires a Pepi signal through an esophageal pressure tester; the noninvasive intraoral surface electromyographic signal acquisition equipment and the esophageal pressure measuring instrument are connected with the polysomnography equipment, and the polysomnography equipment is used for acquiring electroencephalogram signals, nasal airflow signals, thoracoabdominal respiratory motion signals and blood oxygen saturation signals.

In the non-invasive intraoral genioglossus myoelectric activity assessment system, the used non-invasive intraoral surface electromyographic signal acquisition equipment comprises a transparent retainer for mandibular inferior teeth and two spherical electrodes which are manufactured according to the oral fundus and mandibular teeth system of a subject, and two silver chloride spherical electrodes (Natus company, USA) with the diameter of 3mm are embedded on the inner side surface of the manufactured transparent retainer for mandibular inferior teeth by using self-setting plastics and are positioned between the two sides of canine teeth and the lingual side of premolar teeth, and the spherical electrodes are ensured to be in contact with the uplifted part of the genioglossus muscle at the oral fundus.

In summary, the noninvasive intraoral genioglossus myoelectric activity assessment method provided by the invention is used for inducing intraoral surface myoelectric synchronous intracavity negative pressure monitoring technology under sleep, and is established based on AHI index and R_ggEMGThe noninvasive system for evaluating electromyographic activity of genioglossus muscle in mouth of OSA subject can be used for AHI>15 OSA moderate-severe subjects were typed to target AHI>15 the functional factors related to the genioglossus muscle of the moderate-severe OSA subject are objectively evaluated, which is beneficial to providing objective basis for treatment of the factors.

Provides clinically applicable objective evaluation indexes in the aspect of functional pathogenic factors related to the genioglossus muscle. On the AHI-based classification standard of the severity of the classical OSA disease, the classification of R standard deviation <10 and > 10 is increased, and the evaluation of the pathogenic factors of moderate and severe subjects and the classification of clinical phenotype are refined. The noninvasive intraoral genioglossus myoelectric activity assessment system has high safety and applicability. The genioglossus muscle functional activity conditions of different OSA subjects can be noninvasively and accurately divided, so that individualized treatment schemes are formulated for the different OSA subjects, and the treatment effect is improved.

The non-invasive intraoral genioglossus muscle myoelectric activity assessment method and system provided by the invention are explained in detail above. It will be apparent to those skilled in the art that any obvious modifications thereof can be made without departing from the spirit of the invention, which infringes the patent right of the invention and bears the corresponding legal responsibility.

Claims

1. A noninvasive intraoral genioglossus myoelectrical activity assessment method is characterized by comprising the following steps:

s2, aiming at the testee with AHI more than 15, acquiring the following parameters under the condition of intra-oral surface myoelectricity synchronous intra-cavity negative pressure monitoring; respectively acquiring a ggEMG signal parameter value and a Pepi signal parameter value according to 4 stages of resting breath in a waking period, resting breath in an early period of falling asleep, obstructive apnea time period in an N2 sleeping period and resting breath after a nasopharyngeal airway is placed in an N2 sleeping period;

2. The non-invasive intraoral genioglossus myoelectrical activity assessment method according to claim 1, characterized in that: in step S4, when the AHI is greater than 15 and the R standard deviation is greater than or equal to 10, it is determined that the subject is in compliance with the diagnosis of moderate-severe OSA, the genioglossus muscle functional activity is still sufficient, and the disease factor is mainly anatomic stenosis; when AHI is more than 15 and R standard deviation is less than 10, judging that the subject accords with the diagnosis of moderate-severe OSA, the genioglossus muscle functional activity is poor, the posterior area of the tongue is easy to collapse, and the disease factors are comprehensive.

3. The non-invasive intraoral genioglossus myoelectrical activity assessment method according to claim 1, characterized in that: in step S2, the parameter values of the obtained ggEMG signal include: a maximum myoelectric value, a peak myoelectric value, an apnea minimum myoelectric value, and an apnea maximum myoelectric value.

4. The non-invasive intraoral genioglossus myoelectrical activity assessment method according to claim 3, characterized in that: in step S1, all myoelectric original amplitude signals are converted into root mean square values to measure the activation degree of myoelectric.

5. The non-invasive intraoral genioglossus myoelectrical activity assessment method according to claim 3, characterized in that: in step S2, the acquired parameter values of the Pepi signal include: a calm breath Pepi value, an apnea Pepi minimum value, an apnea Pepi maximum value.

6. The non-invasive intraoral genioglossus myoelectrical activity assessment method according to claim 5, characterized in that: in the step S3, the wakeful period unit pressure myoelectric value R1 is the wakeful period peak myoelectric value/wakeful calm breath Pepi value; the myoelectric value R2 of the unit pressure at the early stage of falling asleep is the peak myoelectric value at the early stage of falling asleep/the Pepi value of the quiet breath at the early stage of falling asleep; the apnea minimum unit pressure myoelectric value R3 at N2 is the apnea minimum myoelectric value/apnea Pepi minimum; the apnea maximum unit pressure myoelectric value R4 at N2 is the apnea maximum myoelectric value/apnea Pepi maximum; the unit pressure myoelectric value R5 after the nasopharyngeal airway in the N2 period is equal to the peak myoelectric value after the nasopharyngeal airway in the N2 period is placed/the calm breath Pepi value after the nasopharyngeal airway in the N2 period is placed.

7. A non-invasive intraoral genioglossus myoelectrical activity evaluation system for realizing the non-invasive intraoral genioglossus myoelectrical activity evaluation method according to any one of claims 1 to 6, characterized by comprising: the system comprises an AHI index acquisition module, a ggEMG signal acquisition module, a Pepi signal acquisition module and a data processing module;

8. The non-invasive intraoral genioglossus myoelectrical activity assessment system according to claim 7, comprising:

the ggEMG signal acquisition module acquires ggEMG signals through a non-invasive intraoral surface electromyographic signal acquisition device;

9. The non-invasive intraoral genioglossus myoelectrical activity assessment system according to claim 8, characterized in that:

the noninvasive intraoral surface electromyographic signal acquisition equipment comprises a lower mandible tooth transparent retainer and two silver chloride spherical electrodes, wherein the lower mandible tooth transparent retainer and the two silver chloride spherical electrodes are manufactured according to the oral floor and a lower mandible tooth system of a testee, and the two silver chloride spherical electrodes are embedded on the inner side surface of the lower mandible tooth transparent retainer by self-setting plastics and are positioned between canine teeth on two sides and the lingual side of premolar teeth.

10. The non-invasive intraoral genioglossus myoelectrical activity assessment system according to claim 8, characterized in that:

the polysomnography equipment is used for acquiring electroencephalogram signals, nasal airflow signals, thoracoabdominal respiratory motion signals and oxyhemoglobin saturation signals.