Continuous Positive Airway Pressure (CPAP), Oral Appliance and Physical Exercise in the Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Introduction: It is unclear whether exercise training with or without Continuous Positive Airway Pressure (CPAP) and Oral Appliance (OA) is more effective in reducing symptoms of Obstructive Sleep Apnea (OSA) than treatment solely with CPAP or OA. Objective: In patients with moderate OSA, the investigators will evaluate the effect on the subjective and objective measures of sleep, quality of life and mood of different forms of treatment: exercise training of 4 months; exercise training of 4 months associated with CPAP and OA; treatment with CPAP and treatment with OA. Material and Methods: Sixty male patients (25-65 years, sedentary lifestyle, Body Mass Index (BMI) < 35kg/m2, Apnea-Hypopnea Index (AHI) between 15-30/h, Epworth sleepiness scale > 9) will be divided into three groups: CPAP+exercise group (CE; n=20), OA+exercise group (AE; n=20), and Exercise training group (E; n=20). The patients in groups CE and AE will complete two months of treatment with CPAP or OA to examine the separate effects of these devices. As the patients of the E group did not use the CPAP but will undergo four months of exercise training. After this initial step, patients in CE and AE groups will undergo four months of exercise training associated with CPAP or OA. The investigators will evaluate the subjective sleep parameters (sleep disorders questionnaire, the Epworth Sleepiness Scale, sleep diaries) and objective (polysomnography), Short Form Health Survey (SF-36), Questionnaire Profile of Mood States (POMS) and anthropometric measurements (neck circumference and body composition), the incremental exercise test (ergospirometry) and the one Repetition Maximum test (1RM).

Official Title
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Effects of the Treatment With Continuous Positive Airway Pressure (CPAP) and Oral Appliance, Associated or Not Associated With Physical Exercise, in the Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Continuous Positive Airway Pressure (CPAP)
* Device: Oral Appliance (OA)
* Behavioral: Physical Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects aged between 25 and 65 years old Sedentary according to the criteria of Godin and Shephard (1985) and / or ACSM (2000) Epworth Sleepiness Scale over score of nine Normal range of laboratory tests [blood count, cholesterol, High-density lipoprotein (HDL), triglycerides, fasting glucose, creatinine, Thyroid-stimulating hormone (TSH)] Lung function test (spirometry), chest X-ray (for smokers and former smokers) electrocardiogram (rest and stress) and ENT examination without significant changes Exclusion Criteria: Presence of clinical diseases (chronic obstructive pulmonary disease, asthma, interstitial lung diseases, neuromuscular diseases, heart failure, thyroid disease, rheumatologic and psychiatric) and other sleep disorders Presence of anatomical obstructive upper airway, tonsil grade III and IV septal deviation and grade III (severe) that may affect the outcome of CPAP Loss of posterior dental support to undermine the retention of oral appliance Active periodontal disease, compared Dental crown / dental root less than or equal to 1 (c / r ≤ 1), need for primary dental care (cavities, root canal treatment or retreatment, dentures, ie outlying), open bite Protrusive displacement less than five millimeters Limited mouth opening (would prevent the forming of the dental arches) Alcoholism Uuse of sleep-inducing medications Habits or occupations that lead to sleep deprivation or alteration of the sleep-wake cycle Inability to perform physical exercise, regular history sports activities Intolerance to Continuous Positive Airway Pressure (CPAP) Obesity grade II (moderate) and III (severe)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Positive Airway Pressure (CPAP)<br>CPAP is the gold standard treatment | Device: Continuous Positive Airway Pressure (CPAP)<br>* Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise<br>|
| Active Comparator: Oral Appliance<br>Alternative treatment for obstructive sleep apnea patients | Device: Oral Appliance (OA)<br>* Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise<br>|
| Active Comparator: Physical Exercise<br>Aerobic and resistance physical exercises | Behavioral: Physical Exercise<br>* aerobic and resistance Physical exercise, three times a week, for four months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Sleep Parameters | Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation | 6 months after the basal evaluation | 
| Sleep Apnea | Number of events per hour of sleep | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Markers | Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8 | 6 months after the basal evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obstructive Sleep Apnea, CPAP, Oral appliance, Aerobic exercise, Resistance training