Effects of an Individualized Training Program on Severity Markers of Obstructives Sleep Apnea/Hypopnea Syndrome (OSAS) (REEVASAS)

This study is currently recruiting participants.
Verified October 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01256307
First received: October 28, 2010
Last updated: October 29, 2013
Last verified: October 2013
  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)

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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 2014
Estimated Primary Completion Date: December 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
Criteria

Inclusion Criteria:

  • Presence of an OSAS
  • Apnea Hypopnea Index between 15 and 45/h
  • Sedentary subjects (Voorips Activity questionnaire)
  • IMC<40
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256307

Contacts
Contact: DESPLAN Matthieu, MD 04 67 33 59 08 m-desplan@chu-montpellier.fr

Locations
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         
Sponsors and Collaborators
University Hospital, Montpellier
  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: October 29, 2013
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 April 15, 2014