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Completed

NCT Number: NCT01289392

Continuous Positive Airway Pressure (CPAP), Oral Appliance and 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).

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

25 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Instituto do Sono/Associação Fundo de Incentivo a Psicofarmacologia

São Paulo, 04024-002, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Device

Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise

Oral Appliance (OA)

Device

Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise

Physical exercise

Behavioral

aerobic and resistance Physical exercise, three times a week, for four months

Primary outcomes

  1. Objective Sleep Parameters

    Time frame: 6 months after the basal evaluation

    Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation

  2. Sleep Apnea

    Time frame: 6 months

    Number of events per hour of sleep

Secondary outcomes

  1. Inflammatory Markers

    Time frame: 6 months after the basal evaluation

    Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8

Sponsors and collaborators

Lead sponsor

Associação Fundo de Incentivo à Pesquisa

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
First posted
Feb 3, 2011
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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