Effects of an Individualized Training Program on Severity Markers of Obstructives Sleep Apnea/Hypopnea Syndrome (OSAS) (REEVASAS)
Primary Purpose
Sleep Apnea, Obstructive, Exercise Training Therapy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
training and educational program
educational program
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive Sleep Apnea/Hypopnea Syndrome, Exercise training program, Inflammation, Oxidative Stress, Insulin resistance
Eligibility Criteria
Inclusion Criteria:
- Presence of an OSAS
- Apnea Hypopnea Index between 15 and 45/h
- Sedentary subjects (Voorips Activity questionnaire)
- IMC<40
Sites / Locations
- Montpellier University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
training group
control group
Arm Description
training and educational program
Outcomes
Primary Outcome Measures
change delta index of hourly apneas/hypopneas at eight weeks after inclusion
Secondary Outcome Measures
Full Information
NCT ID
NCT01256307
First Posted
October 28, 2010
Last Updated
December 3, 2014
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT01256307
Brief Title
Effects of an Individualized Training Program on Severity Markers of Obstructives Sleep Apnea/Hypopnea Syndrome (OSAS)
Acronym
REEVASAS
Official Title
Effects of an Individualized Training Program on Severity Markers of Obstructives Sleep Apnea/Hypopnea Syndrome (OSAS)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Exercise Training Therapy
Keywords
Obstructive Sleep Apnea/Hypopnea Syndrome, Exercise training program, Inflammation, Oxidative Stress, Insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
training group
Arm Type
Experimental
Arm Description
training and educational program
Arm Title
control group
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
training and educational program
Intervention Description
8 weeks
Intervention Type
Other
Intervention Name(s)
educational program
Intervention Description
8 weeks
Primary Outcome Measure Information:
Title
change delta index of hourly apneas/hypopneas at eight weeks after inclusion
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of an OSAS
Apnea Hypopnea Index between 15 and 45/h
Sedentary subjects (Voorips Activity questionnaire)
IMC<40
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
32193052
Citation
Bughin F, Desplan M, Mestejanot C, Picot MC, Roubille F, Jaffuel D, Mercier J, Jaussent I, Dauvilliers Y. Effects of an individualized exercise training program on severity markers of obstructive sleep apnea syndrome: a randomised controlled trial. Sleep Med. 2020 Jun;70:33-42. doi: 10.1016/j.sleep.2020.02.008. Epub 2020 Feb 18.
Results Reference
derived
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Effects of an Individualized Training Program on Severity Markers of Obstructives Sleep Apnea/Hypopnea Syndrome (OSAS)
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