Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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In previous review study, it was hypothesized that a comprehensive rehabilitation can combine both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the OSA patients with oropharyngeal muscle dysfunction or ventilator drive instability. To develop a comprehensive rehabilitation model is of innovative care strategy in this study.

Detailed Description
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BACKGROUND: Obstructive sleep apnea (OSA) is a prevalent sleep-related breathing disorder, which was characterized by repetitive events of complete and partial obstructions of the upper airway. The pathogenesis of OSA is interacted by multiple factors, primarily including upper airway (UA) anatomic impairment, ventilatory drive instability, and oropharyngeal muscle dysfunction. However, studies have proven prior oropharyngeal exercise was designed for those OSA patients with oropharyngeal muscle dysfunction. Unlike prior oropharyngeal exercise, comprehensive rehabilitation should emphasize the cardiorespiratory regulation capability in addition to oropharyngeal function. OBJECTIVES: Therefore, the purpose of this study is to explore both the clinical and biological effects of our comprehensive rehabilitation, we used PSG data as clinical effect and biomarker of inflammation expression as biological effect. METHODS: Thirty subjects with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15). In intervention group, a 12-week-intervention of out-patient rehabilitation program included oropharyngeal muscle training, threshold respiratory muscle training, and therapeutic exercise. ANTICIPATED OUTCOMES: The preliminary results would demonstrate promisingly clinical effects and biological effects of our comprehensive rehabilitation model. Therefore, the further studies should emphasize the methods to differentiate diagnosis for the indicated patients with oropharyngeal muscle dysfunction or ventilatory drive instability.

Official Title
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Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea of Adult

Intervention / Treatment
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* Behavioral: comprehensive rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 35-65 with or without surgery had difficulty accepting or adhering CPAP Exclusion Criteria: BMI<32 Smoking or alcoholism Severe allergic rhinitis Stroke history CVD Severe restricted or obstructive pulmonary disease Hypothyroidism DM or HTN without stable control Psychiatric disease Co-existing non-respiratory sleep disorders

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 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
Interventional Model Description: 30 participants with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation' | Behavioral: comprehensive rehabilitation<br>* oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise<br>|
| No Intervention: control group<br>We kept the patients for the waiting list until after completing baseline and 12-week measurement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-hypopea-index | average apnea and hypopnea events per hour during sleep test | Change from Baseline Apnea-hypopnea-index at 12 weeks | 
| potential biomarkers of endothelial dysfunction | count of ICAM-1, VCAM-1, and NF-κB molecule in plasma serum (%) | at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal muscle function | myofunctional scale of genioglossus muscles, mastication muscles, and deglultition muscles | at 12 weeks | 
| Respiratory muscle function | PImax(mmH2O), PEmax(mmH2O) | at 12 weeks | 
| Respiratory muscle function | pulmonary function test (FVC%,FEV1%,FEF50%,FIF50%) | at 12 weeks | 
| Hear rate variability | time domain and frequency domain HRV | at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, oropharyngeal rehabilitation, cardiopulmonary rehabilitation