Follow-up of the Patients Included in the EXESAS Study

Study Overview
=================
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

Official 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

Conditions
-----------------
Sleep Apnea Syndromes, Sleep Apnea, Obstructives

Intervention / Treatment
-----------------
* Other: Training
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training<br>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. | Other: Training<br> <br> * Other names: NeuroGyV program;|
| Other: Control<br>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 | Other: Control<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with AHI<15 through polysomnography assessment after twelve months of follow-up in the training and the control groups. |  | 12 months | 
| Percentage of patients with AHI>30 through polysomnography assessment after twelve months of follow-up in the training and the control groups. |  | 12 months | 
| 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 | 
| Maximal aerobic capacity (VO2Max) | Correlation between the change in VO2max during stress test, walking distance during 6 minutes and AHI in the two groups | 12 months | 
| Population Physical Activity questionnaire (POPAQ) | Correlation between the change in daily physical activity energy expenditure (estimated by the POPAQ questionnaire) and AHI in the two groups | 12 months | 
| Daily physical activity energy expenditure | Correlation between the daily physical activity energy expenditure (estimated directly by an actimetry sensor for 7 days) and AHI in the two groups | 12 months | 
| Epworth sleepiness Scale | Comparison of the variation of Epworth Sleepiness Scale (ESS) after 12 months follow-up for the two groups | 12 months | 
| Pittsburgh questionnaire | Comparison of the variation of Pittsburgh questionnaire after 12 months follow-up for the two groups | 12 months | 
| Berlin questionnaire | Comparison of the variation of Berlin questionnaire after 12 months follow-up for the two groups | 12 months | 
| Changes in blood pressure - Baroreflex | Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Apnea Syndromes, Sleep Apnea, Obstructives, Training