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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
Oral Appliance (OA)
Physical Exercise
Sponsored by
Associação Fundo de Incentivo à Pesquisa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, CPAP, Oral appliance, Aerobic exercise, Resistance training

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Instituto do Sono/Associação Fundo de Incentivo a Psicofarmacologia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Continuous Positive Airway Pressure (CPAP)

Oral Appliance

Physical Exercise

Arm Description

CPAP is the gold standard treatment

Alternative treatment for obstructive sleep apnea patients

Aerobic and resistance physical exercises

Outcomes

Primary Outcome Measures

Objective Sleep Parameters
Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation
Sleep Apnea
Number of events per hour of sleep

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2011
Last Updated
April 25, 2013
Sponsor
Associação Fundo de Incentivo à Pesquisa
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1. Study Identification

Unique Protocol Identification Number
NCT01289392
Brief Title
Continuous Positive Airway Pressure (CPAP), Oral Appliance and Physical Exercise in the Obstructive Sleep Apnea
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associação Fundo de Incentivo à Pesquisa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, CPAP, Oral appliance, Aerobic exercise, Resistance training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Positive Airway Pressure (CPAP)
Arm Type
Active Comparator
Arm Description
CPAP is the gold standard treatment
Arm Title
Oral Appliance
Arm Type
Active Comparator
Arm Description
Alternative treatment for obstructive sleep apnea patients
Arm Title
Physical Exercise
Arm Type
Active Comparator
Arm Description
Aerobic and resistance physical exercises
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Intervention Description
Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise
Intervention Type
Device
Intervention Name(s)
Oral Appliance (OA)
Intervention Description
Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise
Intervention Type
Behavioral
Intervention Name(s)
Physical Exercise
Intervention Description
aerobic and resistance Physical exercise, three times a week, for four months
Primary Outcome Measure Information:
Title
Objective Sleep Parameters
Description
Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation
Time Frame
6 months after the basal evaluation
Title
Sleep Apnea
Description
Number of events per hour of sleep
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Inflammatory Markers
Description
Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8
Time Frame
6 months after the basal evaluation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Instituto do Sono/Associação Fundo de Incentivo a Psicofarmacologia
City
São Paulo
State/Province
SP
ZIP/Postal Code
04024-002
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24037015
Citation
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.
Results Reference
derived

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

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