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

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).

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Continuous Positive Airway Pressure (CPAP); Device: Oral Appliance (OA); Behavioral: Physical Exercise

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04024-002
      • Instituto do Sono/Associação Fundo de Incentivo a Psicofarmacologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Associação Fundo de Incentivo à Pesquisa

Publications and helpful links

General Publications

• Schutz TC, Cunha TC, Moura-Guimaraes T, Luz GP, Ackel-D'Elia C, Alves Eda S, Pantiga G Jr, Mello MT, Tufik S, Bittencourt L. Comparison of the effects of continuous positive airway pressure, oral appliance and exercise training in obstructive sleep apnea syndrome. Clinics (Sao Paulo). 2013;68(8):1168-74. doi: 10.6061/clinics/2013(08)17.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (Estimate): February 3, 2011

Study Record Updates

• Last Update Posted (Estimate): May 3, 2013
• Last Update Submitted That Met QC Criteria: April 25, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Aerobic exercise; Obstructive Sleep Apnea; CPAP; Resistance training; Oral appliance
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: CEP 0352/09