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

Sleep Apnea, Obstructive Clinical Trial

— REEVASAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256307
• Other study ID #: 8508
• Status: Completed
• Phase: N/A
• First received: October 28, 2010
• Last updated: December 3, 2014
• Start date: November 2009
• Est. completion date: July 2013

Study information

• Verified date: December 2014
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Presence of an OSAS

• Apnea Hypopnea Index between 15 and 45/h

• Sedentary subjects (Voorips Activity questionnaire)

• IMC<40

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Exercise Training Therapy
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• training and educational program
8 weeks
• educational program
8 weeks

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change delta index of hourly apneas/hypopneas at eight weeks after inclusion		8 weeks	No