Effects of an Individualized Training Program on Severity Markers of Obstructives Sleep Apnea/Hypopnea Syndrome (OSAS) (REEVASAS)
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Purpose
There are two types of treatments depending on the severity of Obstructive Sleep Apnea/Hypopnea Syndrome (OSAS): - for the treatment of severe (AHI> 30/h), the standard treatment is Continuous Positive Airway Pressure (CPAP). If it proved effective in reducing excessive daytime sleepiness and associated cardiovascular risk, compliance of patients 4 years of treatment falls below 70%. - Treatment of moderate (AHI between 15 and 30/h), lifestyle measures, the bracing of mandibular advancement and / or possibly the head and neck surgery can be proposed. These treatments include side effects and their effectiveness is very controversial.Il therefore seemed interesting to test the impact of physical activity through a standardized training program to re personal effort on the development and improvement of OSAS patients with a sedentary moderate to severe OSAS (AHI between 15 and 40 / h) The main assumption is that the ESR could eventually delay the initiation of treatment with CPAP in severe OSAS or an alternative therapeutic relevance in the moderate OSAS and severe in patients who can not tolerate conventional treatment(CSF). The main objective of this biomedical research is to evaluate the effects of a program of REE in ambulatory index of hourly apneas / hypopneas (AHI = marker of severity of OSAS) .- objectives specify 2AIR effects of REE on the quality of sleep (TxSLP) and daytime symptoms (EDS objective fatigue) on the one hand and the other on the metabolism (OV, SM, IR) and markers of LCR (inflammation, oxidative stress , endothelial function).
| Condition | Intervention |
|---|---|
|
Sleep Apnea, Obstructive Exercise Training Therapy |
Other: training and educational program Other: educational program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of an Individualized Training Program on Severity Markers of Obstructives Sleep Apnea/Hypopnea Syndrome (OSAS) |
- change delta index of hourly apneas/hypopneas at eight weeks after inclusion [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 74 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: training group
training and educational program
|
Other: training and educational program
8 weeks
|
| control group |
Other: educational program
8 weeks
|
Eligibility| Ages Eligible for Study: | 30 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Presence of an OSAS
- Apnea Hypopnea Index between 15 and 45/h
- Sedentary subjects (Voorips Activity questionnaire)
- IMC<40
Contacts and Locations| Contact: DESPLAN Matthieu, MD | 04 67 33 59 08 | m-desplan@chu-montpellier.fr |
| France | |
| Montpellier University Hospital | Recruiting |
| Montpellier, France, 34295 | |
| Contact: DESPLAN Matthieu, MD 04 67 33 59 08 m-desplan@chu-montpellier.fr | |
| Principal Investigator: DESPLAN Matthieu, MD | |
More Information
No publications provided
| Responsible Party: | University Hospital, Montpellier |
| ClinicalTrials.gov Identifier: | NCT01256307 History of Changes |
| Other Study ID Numbers: | 8508 |
| Study First Received: | October 28, 2010 |
| Last Updated: | March 26, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Montpellier:
|
Obstructive Sleep Apnea/Hypopnea Syndrome Exercise training program Inflammation Oxidative Stress Insulin resistance |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013