Clinical trial NCT02463890: Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity
Official title: Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndromes
Sleep Apnea, Obstructives
Keywords: Sleep Apnea Syndromes
Sleep Apnea, Obstructives
Training
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 96
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Final polysomnography
timeFrame: 9 months
Secondary outcomes:
measure: First intermediate polysomnography
timeFrame: 3 months
measure: Second intermediate polysomnography
timeFrame: 6 months
measure: High frequency
timeFrame: 9 months
measure: Maximal aerobic capacity (VO2Max)
timeFrame: 9 months
measure: Population Physical Activity questionnaire (POPAQ)
timeFrame: 9 months
measure: Daily physical activity energy expenditure
timeFrame: 9 months
measure: Epworth sleepiness Scale
timeFrame: 9 months
measure: Pittsburgh questionnaire
timeFrame: 9 months
measure: Berlin questionnaire
timeFrame: 9 months
measure: Blood pressure - Baroreflex
timeFrame: 9 months
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Frederic ROCHE, MD - PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berger M, Barthelemy JC, Hupin D, Raffin J, Dupre C, Labeix P, Costes F, Gaspoz JM, Roche F. Benefits of supervised community physical activity in obstructive sleep apnoea. Eur Respir J. 2018 Nov 22;52(5):1801592. doi: 10.1183/13993003.01592-2018. Print 2018 Nov. No abstract available.