Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea

Study Overview
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Brief Summary
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The effects of orofarangeal exercises (OE) and inspiratory muscle training (IMT) on sleep quality, disease severity, and airway muscle tone have been investigated in several studies. IMT and OE exercise modalities for patients and practitioners have advantages and disadvantages. It is recommended to compare exercise modalities in the studies. Whether OE or IMT exercise type is more effective on disease severity, sleep quality and snoring has not been investigated. The aim of this study was to compare the effectiveness of inspiratory muscle training and oropharyngeal exercises in patients with OSAS in terms of disease severity, snoring, daytime sleepiness, respiratory muscle strength and sleep quality.

Official Title
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Comparison of the Effectiveness of Inspiratory Muscle Training and Oropharyngeal Exercises in Patients With Obstructive Sleep Apnea Syndrome: a Randomized Controlled Trial

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Other: respiratory muscle strengthening exercise
* Other: oropharyngeal muscles strengthening exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: *To be diagnosed with mild, moderate and severe OSAS. Exclusion Criteria: Patients with a history of stroke, neurological disease, severe obstructive nasal disease, and infection in the last month, BMI being 40 kg /m2 or more.

Ages Eligible for Study
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Minimum Age: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oropharyngeal exercises<br>Oropharyngeal exercises include soft palate, tongue and facial muscle exercises as well as stomatognathic function exercises. Training sessions were held once a day, 5 days a week for 12 weeks under the supervision of a mirror. | Other: oropharyngeal muscles strengthening exercise<br>* These exercises strengthen locally oropharyngeal muscles. Oropharyngeal exercise can be done with some facial movements .<br>|
| Experimental: Inspiratory muscle training<br>The inspiratory muscle training group was administered for 12 weeks starting from 30% of maximal oral pressure, 7 days a week, 15 minutes twice a day. Patients came to the control once a week, mouth pressures were measured and training pressure was adjusted in 30% of the new value. | Other: respiratory muscle strengthening exercise<br>* These exercises strengthen locally inspiratory muscles. IMT can be done with threshold loaded devices.<br>|
| No Intervention: Control<br>This group was only monitorized without any rehabilitation intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography | Sleep efficiency, apnea-hypopnea index (AHI). Higher sleep efficiency and lower AHI values shows that patient have better status and lower disease severity | 2 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal inspiratory and expiratory muscle strength measurement with mouth pressure device | Respiratory muscle strength | 6 day | 
| 6 minute walk test | Exercise capacity | 2 day | 
| Epworth Sleepiness Scale | minimum and maximum scores: 0-24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness' | 2 day | 
| Berlin Questionnaire | Snoring frequency (0-3) and severity (0-4). Higher scores show higher snoring frequency and severity | 2 day | 
| Functional Outcomes of Sleep Questionnaire | Quality of life related with sleep. Minimum and maximum scores: 0-16. Higher scores show worse sleep related quality of life | 2 day | 
| The Pittsburgh Sleep Quality Index | Sleep quality. Minimum and maximum scores: 0-21. Higher scores show worse sleep quality | 2 day | 
| Fatigue Severity Scale | Fatigue severity. Minimum and maximum scores: 0-7. 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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obstructive sleep apnea, oropharyngeal exercises, inspiratory muscle training, sleep quality