An interventional study of Continuous Positive Airway Pressure (CPAP) and Oral Appliance (OA) in Obstructive Sleep Apnea, sponsored by Associação Fundo de Incentivo à Pesquisa. Completed at 1 site in Brazil. Open to male participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-05-03.
Sponsored by Associação Fundo de Incentivo à Pesquisa · Not applicable, Interventional, and Treatment
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).
1,422 studies on the registry are indexed under Apnea; 160 are open to participants now.
This study's enrollment of 25 is below the median of 51 across 966 interventional studies indexed under Apnea.
Browse Apnea studies →Associação Fundo de Incentivo à Pesquisa is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CPAP is the gold standard treatment
Device: Continuous Positive Airway Pressure (CPAP)
Alternative treatment for obstructive sleep apnea patients
Device: Oral Appliance (OA)
Aerobic and resistance physical exercises
Behavioral: Physical Exercise
Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise
Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise
aerobic and resistance Physical exercise, three times a week, for four months
Objective Sleep Parameters
Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation
Time frame: 6 months after the basal evaluation
Sleep Apnea
Number of events per hour of sleep
Time frame: 6 months
Inflammatory Markers
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
sleep disorder clinic
| Milestone | Continuous Positive Airway Pressure (CPAP) | Oral Appliance | Physical Exercise |
|---|---|---|---|
| Started | 9 | 9 | 7 |
| Completed | 9 | 9 | 7 |
| Not completed | 0 | 0 | 0 |
Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation
Results for this outcome have not been posted.
Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8
Results for this outcome have not been posted.
Number of events per hour of sleep
| number of events | Continuous Positive Airway Pressure (CPAP) | Oral Appliance | Physical Exercise |
|---|---|---|---|
| Sleep Apnea | 25.06 ± 10.54 | 30.76 ± 19.00 | 22.81 ± 12.77 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | — | 0/9 (0%) | — |
| Oral Appliance | — | 0/9 (0%) | — |
| Physical Exercise | — | 0/7 (0%) | — |
| Age, Categorical(Participants) | Continuous Positive Airway Pressure (CPAP) | Oral Appliance | Physical Exercise | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 9 | 7 | 25 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age Continuous(years) | Continuous Positive Airway Pressure (CPAP) | Oral Appliance | Physical Exercise | Total |
|---|---|---|---|---|
| Mean | 38.62 ± 8.15 | 42.33 ± 6.20 | 42.28 ± 8.28 | 41.10 ± 7.27 |
| Sex: Female, Male(Participants) | Continuous Positive Airway Pressure (CPAP) | Oral Appliance | Physical Exercise | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 9 | 9 | 7 | 25 |
| Region of Enrollment(participants) | Continuous Positive Airway Pressure (CPAP) | Oral Appliance | Physical Exercise | Total |
|---|---|---|---|---|
| Brazil | 9 | 9 | 7 | 25 |
This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.
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Associação Fundo de Incentivo à Pesquisa