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

NCT01289392 | Completed Results DMC

• 1 other identifier: CEP 0352/09
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obstructive Sleep Apnea; CPAP; Oral appliance; Aerobic exercise; Resistance training

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Inflammatory Markers

  6 months after the basal evaluation

Study Arms (3)

Continuous Positive Airway Pressure (CPAP)

ACTIVE COMPARATOR

CPAP is the gold standard treatment

Device: Continuous Positive Airway Pressure (CPAP)

Oral Appliance

ACTIVE COMPARATOR

Alternative treatment for obstructive sleep apnea patients

Device: Oral Appliance (OA)

Physical Exercise

ACTIVE COMPARATOR

Aerobic and resistance physical exercises

Behavioral: Physical Exercise

Interventions

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

Continuous Positive Airway Pressure (CPAP)

Oral Appliance (OA) DEVICE

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

Oral Appliance

Physical Exercise BEHAVIORAL

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

Physical Exercise

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Associação Fundo de Incentivo à Pesquisa: lead

Study Sites (1)

Instituto do Sono/Associação Fundo de Incentivo a Psicofarmacologia

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (1)

• 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.

  PMID: 24037015 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr Teresa Cristina Barros Schutz
• Organization: Associação Fundo de Incentivo à Pesquisa

schutzferraz@gmail.com

55-21-99868033

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 3, 2011
• Study Start: October 1, 2010
• Primary Completion: January 1, 2013
• Last Updated: May 3, 2013
• Results First Posted: April 12, 2013

Record last verified: 2013-03

Locations

BR (1)