Sleep Apnea, Obstructives, Sleep Apnea Syndromes
Conditions
Keywords
Sleep Apnea Syndromes, Sleep Apnea, Obstructives, Training
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.
Interventions
OTHERTraining
OTHERControl
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Final polysomnography | 9 months | Percentage of patients with AHI \< 15/hour through polysomnography assessment after nine months of follow-up in the training and the control groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Second intermediate polysomnography | 6 months | Percentage of patients with AHI\<15/hour through polysomnography assessment after six months of follow-up in the training and the control groups. |
| High frequency | 9 months | 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 |
| Maximal aerobic capacity (VO2Max) | 9 months | Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups |
| Population Physical Activity questionnaire (POPAQ) | 9 months | Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups |
| First intermediate polysomnography | 3 months | Percentage of patients with AHI\<15/hour through polysomnography assessment after three months of follow-up in the training and the control groups. |
| Epworth sleepiness Scale | 9 months | Comparison of the variation of Epworth Sleepiness Scale (ESS) after 9 months follow-up for the two groups |
| Pittsburgh questionnaire | 9 months | Comparison of the variation of Pittsburgh questionnaire after 9 months follow-up for the two groups |
| Berlin questionnaire | 9 months | Comparison of the variation of Berlin questionnaire after 9 months follow-up for the two groups |
| Blood pressure - Baroreflex | 9 months | Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure |
| Daily physical activity energy expenditure | 9 months | Correlation between the daily physical activity energy expenditure (estimated directly by an actimetry sensor for 7 days) and AHI in the two groups |
Countries
France
Outcome results
None listed