Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea, CPAP, Oral appliance, Aerobic exercise, Resistance training
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).
Interventions
DEVICEContinuous 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
DEVICEOral Appliance (OA)
Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise
BEHAVIORALPhysical Exercise
aerobic and resistance Physical exercise, three times a week, for four months
Sponsors
Associação Fundo de Incentivo à Pesquisa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
25 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Sleep Parameters | 6 months after the basal evaluation | Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation |
| Sleep Apnea | 6 months | Number of events per hour of sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Markers | 6 months after the basal evaluation | Blood samples to test: tumor necrosis factor-alpha (TNF-alpha), C-reactive protein (CRP), Interleukin-6 and Interleukin-8 |
Countries
Brazil
Participant flow
Recruitment details
sleep disorder clinic
Participants by arm
| Arm | Count |
|---|---|
| Continuous Positive Airway Pressure (CPAP) CPAP is the gold standard treatment
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 | 9 |
| Oral Appliance Alternative treatment for obstructive sleep apnea patients
Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise | 9 |
| Physical Exercise Aerobic and resistance physical exercises
Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months | 7 |
| Total | 25 |
Baseline characteristics
| Characteristic | Oral Appliance | Physical Exercise | Continuous Positive Airway Pressure (CPAP) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 7 Participants | 9 Participants | 25 Participants |
| Age Continuous | 42.33 years STANDARD_DEVIATION 6.2 | 42.28 years STANDARD_DEVIATION 8.28 | 38.62 years STANDARD_DEVIATION 8.15 | 41.10 years STANDARD_DEVIATION 7.27 |
| Region of Enrollment Brazil | 9 participants | 7 participants | 9 participants | 25 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 9 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 7 |
Outcome results
Primary
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
Primary
Sleep Apnea
Number of events per hour of sleep
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | Sleep Apnea | 25.06 number of events | Standard Deviation 10.54 |
| Oral Appliance | Sleep Apnea | 30.76 number of events | Standard Deviation 19 |
| Physical Exercise | Sleep Apnea | 22.81 number of events | Standard Deviation 12.77 |
Secondary
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