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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289392
• Other study ID #: CEP 0352/09
• Status: Completed
• Phase: N/A
• First received: January 31, 2011
• Last updated: April 25, 2013
• Start date: October 2010

Study information

• Verified date: March 2013
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Comissão Nacional de Ética em Pesquisa
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Instituto do Sono/Associação Fundo de Incentivo a Psicofarmacologia	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Sleep Parameters	Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation	6 months after the basal evaluation	No
Primary	Sleep Apnea	Number of events per hour of sleep	6 months	Yes
Secondary	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	No