NCT01289392

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Associação Fundo de Incentivo à Pesquisa · Academic / Other
• Sex: Male
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Continuous Positive Airway Pressure (CPAP)	Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise
DEVICE	Oral Appliance (OA)	Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise
BEHAVIORAL	Physical Exercise	aerobic and resistance Physical exercise, three times a week, for four months

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-01-01
• First posted: 2011-02-03
• Last updated: 2013-05-03
• Results posted: 2013-04-12

Locations

1 site across 1 country: Brazil