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Completed

NCT Number: NCT02463890

Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea, Obstructives Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training

Other

Other names: NeuroGyV program

Control

Other

Primary outcomes

  1. Final polysomnography

    Time frame: 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 outcomes

  1. First intermediate polysomnography

    Time frame: 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.

  2. Second intermediate polysomnography

    Time frame: 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.

  3. High frequency

    Time frame: 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

  4. Maximal aerobic capacity (VO2Max)

    Time frame: 9 months

    Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups

  5. Population Physical Activity questionnaire (POPAQ)

    Time frame: 9 months

    Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups

  6. Daily physical activity energy expenditure

    Time frame: 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

  7. Epworth sleepiness Scale

    Time frame: 9 months

    Comparison of the variation of Epworth Sleepiness Scale (ESS) after 9 months follow-up for the two groups

  8. Pittsburgh questionnaire

    Time frame: 9 months

    Comparison of the variation of Pittsburgh questionnaire after 9 months follow-up for the two groups

  9. Berlin questionnaire

    Time frame: 9 months

    Comparison of the variation of Berlin questionnaire after 9 months follow-up for the two groups

  10. Blood pressure - Baroreflex

    Time frame: 9 months

    Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: EXESAS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 4, 2015
Registry last updated
Feb 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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