Follow-up of the Patients Included in the EXESAS Study

Sleep Apnea Syndromes Clinical Trial

— FOLLOW_EXESAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920723
• Other study ID #: 1608082
• Secondary ID: 2016-A00859-42
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: August 21, 2018

Study information

• Verified date: November 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: August 21, 2018
• Est. primary completion date: August 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Apnea, Obstructives

Intervention

Other:
• Training

• Control

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients with AHI<15 through polysomnography assessment after twelve months of follow-up in the training and the control groups.		12 months
Secondary	Percentage of patients with AHI>30 through polysomnography assessment after twelve months of follow-up in the training and the control groups.		12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Epworth sleepiness Scale	Comparison of the variation of Epworth Sleepiness Scale (ESS) after 12 months follow-up for the two groups	12 months
Secondary	Pittsburgh questionnaire	Comparison of the variation of Pittsburgh questionnaire after 12 months follow-up for the two groups	12 months
Secondary	Berlin questionnaire	Comparison of the variation of Berlin questionnaire after 12 months follow-up for the two groups	12 months
Secondary	Changes in blood pressure - Baroreflex	Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure	12 months

External Links

•   Website of the FFEPGV (in french)