High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome

Study Overview
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Brief Summary
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The effect of expiratory muscle strength training (EMST) on sleep quality, disease severity, and respiratory muscle strength has been previously investigated in OSA syndrom. Only the effects of the high-intensity short-term EMST study in moderate OSAS patients were studied. High intensity and low intensity EMST has advantages and disadvantages.The study aims to compare the effects of high (60% MEP) and low (30% MEP) expiratory muscle strength training (EMST) on disease severity, sleep efficiency, snoring, fatigue severity and quality of life in severe OSAS patients.

Detailed Description
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Ahi Evren Chest Cardiovascular Surgery Training Research Hospital In sleep lab, polysomnography will be directed to the physiotherapist by the pulmonologist with severe OSAS patients. Patients will be divided into two groups by block randomization method. The study was planned as double-blind. Patients will not know what treatment they are receiving, the doctor does not know what treatment the patient is receiving, and technicians who take and analyze polysomnography will not know what treatment the patients are receiving. Severe OSAS patients with MEP 30% (low intensity) to the first group, MEP 60% (high intensity) to the second group with expiratory muscle training device, 7 days / week, 25 breaths per day, 1 minute rest for 5 breaths will be run with the cycle. The training will take a total of 8 weeks. The follow-up of the patients will be done remotely by phone. MEP measurements will be repeated every 2 weeks in the hospital and the new training workload will be calculated.

Official Title
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Comparison of the Effects of High and Low Intensity Expiratory Muscle Strength Training in Patients With Obstructive Sleep Apnea Syndrome

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Other: Expiratory muscle trainig


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with severe OSAS by Polysomnography in Ahi Evren Chest, Cardiovascular Surgery Training and Research Hospital Sleep Center will be included. General health condition is stable Exclusion Criteria: Passed stroke, Neurological disease and psychological disease Cardiac disease Hypothyroidism Serious obstructive nasal disease, A history of infection in the past month. Previous oroferengeal surgery history With a BMI of 40 kg / m2 or more, Using substance, alcohol, sedative and hypnotic drugs

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L-EMST<br>At 30% of the maximum expiratory pressure (MEP), 25 breaths, 7 days / week, a total of 8 weeks will be trained once a day with a 1-minute rest cycle in 5 breaths. Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 30% of the new measurement. | Other: Expiratory muscle trainig<br>* This exercise will be used to strengthen forced expiratory muscles.<br>|
| Active Comparator: H-EMST<br>In 60% of the maximum expiratory pressure (MEP), 25 breaths a day, 7 days / week, a total of 8 weeks will be trained with a 1-minute rest cycle in 5 breaths. Patients will be invited to control every 2 weeks. MEP measurements will be repeated and the training value will be adjusted in 60% of the new measurement. | Other: Expiratory muscle trainig<br>* This exercise will be used to strengthen forced expiratory muscles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease severity | Polysomnography recordings will be taken especially sleep efficiency and apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity | 2 day | 
| Respiratory muscle strength | Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device | 5 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime sleepiness | Epworth Sleepiness Scale (ESS). Minimum and maximum scores: 0-24. The higher ESS score means the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness' | 2 day | 
| Snoring severitiy and frequency | Berlin Questionnaire: Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity. | 2 day | 
| Sleep quality | The Pittsburgh Sleep Quality Index (PSQI). Minimum and maximum scores: 0-21. Higher PSQI scores show worse sleep quality. | 2 day | 
| Fatigue severity. | Fatigue Severity Scale (FSS) . Minimum and maximum scores: 0-7. FSS scores higher than 4 shows high intensity fatigue perception | 2 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Expiratory muscle strength training, Snoring, Sleep quality, EMST