Follow-up of the Patients Included in the EXESAS Study

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructives
• Interventions: Other: Control; Other: Training

• Registration Number: NCT02920723
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

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

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Primary Completion: 2018-08-21
• Study Completion: 2018-08-21
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-02
• Last Update Posted: 2018-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	For the patients who were allocated in the training group in the EXESAS study. In this group, patients will receive only diets and physical activity counselling
Training	Training	For the patients who were allocated in the control group in the EXESAS study. In this group, patients will perform 3 sessions of one hour per week of the "NeuroGyV" training program. It is a physical activity program with one session of Nordic walking, one session of "aquagym" and one session of gymnastic. Program lasts 9 months.

Primary Outcome Measures

Name	Time	Method
the AHI (number of Apnea+Hypopnea per hour) through polysomnography assessment after twelve months of follow-up in the training and the control groups	12 months	Apnea-Hypopnea Index (AHI)

Secondary Outcome Measures

Name	Time	Method
Maximal aerobic capacity (VO2Max)	12 months	Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups
Epworth sleepiness Scale	12 months	Comparison of the variation of Epworth Sleepiness Scale (ESS) after 12 months follow-up for the two groups
Change in high frequency (HF) of spectral analysis of heart rate variability (parasympathetic index) at 12 months of follow-up in the 2 groups	12 months
Berlin questionnaire	12 months	Comparison of the variation of Berlin questionnaire after 12 months follow-up for the two groups
Percentage of patients with AHI>30 through polysomnography assessment after twelve months of follow-up in the training and the control groups.	12 months
Daily physical activity energy expenditure	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
Pittsburgh questionnaire	12 months	Comparison of the variation of Pittsburgh questionnaire after 12 months follow-up for the two groups
Percentage of patients with AHI<15 through polysomnography assessment after twelve months of follow-up in the training and the control groups.	12 months
Population Physical Activity questionnaire (POPAQ)	12 months	Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups
Changes in blood pressure - Baroreflex	12 months	Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France