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Completed

NCT Number: NCT02920723

Follow-up of the Patients Included in the EXESAS Study

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.

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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

About this study

In the previous EXESAS study (NCT02463890) the investigators compare evolution of Apnea 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.

The first partial observations of the study EXESAS seem encouraging in the term of 3 months of training. However, in the longer term, there is not a coverage in the treatment of the moderate Sleep Apnea: Obstructive Syndrome (SAOS). Thus they can logically expect that the possible therapeutic effect of the exercise is not maintained in the long term after the stop of the training.

This nex study suggests studying the profit of the exercise on sleep apneas for the patients who were initially in the control group in the EXESAS study and to observe if the preservation of a regular physical activity for the group which was trained in EXESAS study is associated with a preservation of the AHI after the additional year of follow-up without additional intervention

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Included in the previous EXESAS study
  • 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
  • AHI > 30

Treatment and study plan

Training

Other

Other names: NeuroGyV program

Control

Other

Primary outcomes

  1. the AHI (number of Apnea+Hypopnea per hour) through polysomnography assessment after twelve months of follow-up in the training and the control groups

    Time frame: 12 months

    Apnea-Hypopnea Index (AHI)

Secondary outcomes

  1. Percentage of patients with AHI<15 through polysomnography assessment after twelve months of follow-up in the training and the control groups.

    Time frame: 12 months

  2. Percentage of patients with AHI>30 through polysomnography assessment after twelve months of follow-up in the training and the control groups.

    Time frame: 12 months

  3. Change in high frequency (HF) of spectral analysis of heart rate variability (parasympathetic index) at 12 months of follow-up in the 2 groups

    Time frame: 12 months

  4. Maximal aerobic capacity (VO2Max)

    Time frame: 12 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: 12 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: 12 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: 12 months

    Comparison of the variation of Epworth Sleepiness Scale (ESS) after 12 months follow-up for the two groups

  8. Pittsburgh questionnaire

    Time frame: 12 months

    Comparison of the variation of Pittsburgh questionnaire after 12 months follow-up for the two groups

  9. Berlin questionnaire

    Time frame: 12 months

    Comparison of the variation of Berlin questionnaire after 12 months follow-up for the two groups

  10. Changes in blood pressure - Baroreflex

    Time frame: 12 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

Official study title

Follow-up of the Patients Included in the EXESAS Study : Analysis of the Profit of the Physical Activity for the Control Group and of the Preservation of a Regular Physical Activity for the Group Initially Trained

Acronym: FOLLOW_EXESAS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 30, 2016
Registry last updated
Nov 5, 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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