NCT01256307

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 8, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

3.7 years

First QC Date

October 28, 2010

Last Update Submit

December 3, 2014

Conditions

Sleep Apnea, ObstructiveExercise Training Therapy

Keywords

Obstructive Sleep Apnea/Hypopnea SyndromeExercise training programInflammationOxidative StressInsulin resistance

Outcome Measures

Primary Outcomes (1)

  • change delta index of hourly apneas/hypopneas at eight weeks after inclusion

    8 weeks

Study Arms (2)

training group

EXPERIMENTAL

training and educational program

Other: training and educational program

control group

OTHER
Other: educational program

Interventions

training and educational programOTHER

8 weeks

training group
educational programOTHER

8 weeks

control group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of an OSAS
  • Apnea Hypopnea Index between 15 and 45/h
  • Sedentary subjects (Voorips Activity questionnaire)
  • IMC\<40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 32193052DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveInflammationInsulin Resistance

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2010

First Posted

December 8, 2010

Study Start

November 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

FR(1)