Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA

Study Overview
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Brief Summary
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Objectives: To observe the effect of newly-created individualized upper airway muscle functional training on the condition and intraday symptoms of OSA patients; to study the effect of this training method on the excitability of the genioglossus muscle cortex; to analyze the factors affecting the efficacy of upper airway training in the treatment of OSA and screening suitable population for upper airway training: Design: A randomized double-blind controlled trial. SAS 9.3 statistical software (SAS Institute, Cary, North Carolina, USA) was used to generate a random number table, and the selected patients were randomly divided into experimental group 1, experimental group 2, and control group according to the ratio of 1:1:1 with 100 cases each. Unit: Shenyang, China Participants: Consecutive specific OSA patients, who are potential candidates for the treatment of upper airway training (n=300), will be recruited from a sleep center or respirologists, psychiatrists, otolaryngologists and dentists practicing with broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI<40 kg/m2). Interventions: The three groups of subjects completed 7-day functional training and control training of upper airway muscles in different modes, respectively completed polysomnography, neck circumference, Berlin questionnaire and Epworth sleepiness scale before and after training, The genioglossus myoelectric activity was measured after transcranial magnetic stimulation and the excitability of the genioglossus cortex motor center was used to determine the efficacy of different training. After regression analysis, the factors affecting the efficacy of upper airway muscle group training were analyzed to screen the OSA patient population suitable for upper airway muscle group training.

Official Title
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Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA

Conditions
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Obstructive Sleep Apnea, Muscle Disorder

Intervention / Treatment
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* Behavioral: New individualized upper airway muscle functional training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recent diagnosis of OSA (AHI>15 events/h) announced by a sleep recording Mean oxygen saturation >90% Must be able to complete the training Exclusion Criteria: Inability to tolerate overnight polysomnography in sleep lab >50% of observed sleep apneas being central Other sleep disorders such as insomnia, narcolepsy, chronic sleep deficiency, periodic limb movement disorder or restless legs syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tongue/soft palate muscle control function training group<br>In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor | Behavioral: New individualized upper airway muscle functional training<br>* The two groups of experimental groups were respectively performed tongue/soft palate muscle group control function training and soft palate muscle group vocal resistance training for 7 days.<br>|
| Experimental: Soft palate muscle group vocal resistance training group<br>In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor | Behavioral: New individualized upper airway muscle functional training<br>* The two groups of experimental groups were respectively performed tongue/soft palate muscle group control function training and soft palate muscle group vocal resistance training for 7 days.<br>|
| Placebo Comparator: Simple tongue extension, cheek drumming/voice training group<br>In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor | Behavioral: New individualized upper airway muscle functional training<br>* The two groups of experimental groups were respectively performed tongue/soft palate muscle group control function training and soft palate muscle group vocal resistance training for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Parameters Changes : Apnea Hypopnea Index (AHI) | Overnight polysomnography with Alice5 (Philips); AHI measured according to American Association of Sleep Medicine (AASM) criteria | Baseline and 1 Week | 
| Sleep Parameters Changes : Oxygen desaturation index (ODI) | Overnight polysomnography with Alice5 (Philips); ODI measured according to American Association of Sleep Medicine (AASM) criteria | Baseline and 1 Week | 
| Sleep Parameters Changes : Snoring index | Overnight polysomnography with Alice5 (Philips); Snoring index measured according to American Association of Sleep Medicine (AASM) criteria | Baseline and 1 Week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Airway Muscle Strength (genioglossus) | Measurement of Genioglossus Strength Using the New Individualized Upper Airway Muscle Training Machine: Measuring Tongue Extension Strength (N) | Baseline and 1 Week | 
| Upper Airway Muscle Strength (Soft palate muscles) | Measuring Soft Palate Muscle Strength Using the New Personalized Upper Airway Muscle Training Machine: Measuring Soft Palate Muscle Resistant Pressure (kPa) | Baseline and 1 Week | 
| Quality of Life (as measured by Berlin Questionnaire) | The Berlin scale was used to assess the degree of risk of obstructive sleep apnea-hypopnea syndrome. The questionnaire consisted of 10 questions divided into 3 categories: snoring and apnea (5 questions); excessive daytime sleepiness or fatigue (3 questions); BMI>30 and history of hypertension. 2 or more positive results indicate a high risk of obstructive sleep apnea-hypopnea syndrome, which should be checked by the subjects, and then scored by the medical staff. | Baseline and 1 Week | 
| Cortical motor center excitability of upper airway muscle | Measured byTranscranial Magnetic Stimulation Machine (Nihon Nkohdencorp) : amplitude (mV) | Baseline and 1 Week | 
| Daytime sleepiness (as measured by Epworth Sleepiness Scale) | Scores on Epworth Sleepiness Scale range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness). | Baseline and 1 Week |