Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity

Sleep Apnea Syndromes Clinical Trial

— EXESAS  

Official title:

Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463890
• Other study ID #: 1508033
• Secondary ID: 2015-A00490-49
• Status: Completed
• Phase: N/A
• First received: June 3, 2015
• Last updated: February 15, 2018
• Start date: June 8, 2015
• Est. completion date: September 4, 2017

Study information

• Verified date: February 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It does multiply tenfold the occurrence of vascular events, particularly stroke. While Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to CPAP is a significant problem and search for alternative treatment is essential.

The investigators hypothesize that long-term exercise training would allow to reduce significantly sleep apnoea syndrome severity. Thus, in this study, the investigators will compare evolution of Apnoea Hypopnea Index (AHI) in an exercise trained group performed through in a national based non-profit organization (Fédération Française d'éducation Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program (NeuroGyV) during nine months against a control group receiving only standard dietetic and physical activity counseling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 4, 2017
• Est. primary completion date: September 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients affiliated or entitled to a social security system

• Patients with AHI from 15 to 30 per hour

• Signature of consent

Exclusion Criteria:

• Patients being already treated for sleep apnea or clinical status (cardiovascular comorbidities) justifying an immediate initiation of CPAP

• Daytime sleepiness (ESS score > 10)

• Known respiratory or heart disease (or discovering during stress test) contraindicated exercise training

• Patients with Parkinson's disease

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Apnea, Obstructives
• Syndrome

Intervention

Other:
• Training

• Control

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final polysomnography	Percentage of patients with AHI < 15/hour through polysomnography assessment after nine months of follow-up in the training and the control groups	9 months
Secondary	First intermediate polysomnography	Percentage of patients with AHI<15/hour through polysomnography assessment after three months of follow-up in the training and the control groups.	3 months
Secondary	Second intermediate polysomnography	Percentage of patients with AHI<15/hour through polysomnography assessment after six months of follow-up in the training and the control groups.	6 months
Secondary	High frequency	Correlation between change in AHI and change in high frequency (HF) of spectral analysis of heart rate variability (parasympathetic index) at 9 months of follow-up in the 2 groups	9 months
Secondary	Maximal aerobic capacity (VO2Max)	Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups	9 months
Secondary	Population Physical Activity questionnaire (POPAQ)	Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups	9 months
Secondary	Daily physical activity energy expenditure	Correlation between the daily physical activity energy expenditure (estimated directly by an actimetry sensor for 7 days) and AHI in the two groups	9 months
Secondary	Epworth sleepiness Scale	Comparison of the variation of Epworth Sleepiness Scale (ESS) after 9 months follow-up for the two groups	9 months
Secondary	Pittsburgh questionnaire	Comparison of the variation of Pittsburgh questionnaire after 9 months follow-up for the two groups	9 months
Secondary	Berlin questionnaire	Comparison of the variation of Berlin questionnaire after 9 months follow-up for the two groups	9 months
Secondary	Blood pressure - Baroreflex	Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure	9 months

External Links

•   Website of the FFEPGV (in french)