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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier:
NCT01289392
First received: January 31, 2011
Last updated: April 25, 2013
Last verified: March 2013
  Purpose

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).


Condition Intervention
Obstructive Sleep Apnea
Device: Continuous Positive Airway Pressure (CPAP)
Device: Oral Appliance (OA)
Behavioral: Physical Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Associação Fundo de Incentivo à Pesquisa:

Primary Outcome Measures:
  • Objective Sleep Parameters [ Time Frame: 6 months after the basal evaluation ] [ Designated as safety issue: No ]
    Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation

  • Sleep Apnea [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number of events per hour of sleep


Secondary Outcome Measures:
  • Inflammatory Markers [ Time Frame: 6 months after the basal evaluation ] [ Designated as safety issue: No ]
    Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8


Enrollment: 25
Study Start Date: October 2010
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289392

Locations
Brazil
Instituto do Sono/Associação Fundo de Incentivo a Psicofarmacologia
São Paulo, SP, Brazil, 04024-002
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
  More Information

No publications provided by Associação Fundo de Incentivo à Pesquisa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Lia Azeredo-Bittencourt, professor, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier: NCT01289392     History of Changes
Other Study ID Numbers: CEP 0352/09
Study First Received: January 31, 2011
Results First Received: January 28, 2013
Last Updated: April 25, 2013
Health Authority: Brazil: Comissão Nacional de Ética em Pesquisa

Keywords provided by Associação Fundo de Incentivo à Pesquisa:
Obstructive Sleep Apnea
CPAP
Oral appliance
Aerobic exercise
Resistance training

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2014