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
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).
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05857384 -
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
|
Phase 1 | |
| Recruiting |
NCT04547543 -
Follow-up of Apneic Patients by Visio-consultation
|
N/A | |
| Recruiting |
NCT05371509 -
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
|
N/A | |
| Completed |
NCT02515357 -
Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea
|
N/A | |
| Completed |
NCT05582070 -
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
|
N/A | |
| Active, not recruiting |
NCT03189173 -
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
|
Phase 2 | |
| Completed |
NCT04084899 -
The Effect of CPAP on Lung Hyperinflation in Patients With OSA
|
||
| Completed |
NCT03032029 -
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
|
||
| Recruiting |
NCT04028011 -
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
|
||
| Recruiting |
NCT06047353 -
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
|
N/A | |
| Completed |
NCT05253963 -
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
|
N/A | |
| Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
| Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
| Completed |
NCT03589417 -
Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
|
||
| Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
| Withdrawn |
NCT04063436 -
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
|
N/A | |
| Recruiting |
NCT05385302 -
Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
|
||
| Recruiting |
NCT04572269 -
Metabolomics of Obstructive Sleep Apnea
|
||
| Not yet recruiting |
NCT06467682 -
12-week Tele-exercise Program in Patients With OSA
|
N/A | |
| Withdrawn |
NCT04011358 -
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
|
N/A |