Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea

Active, not recruiting

• Conditions: Healthy

• Registration Number: NCT00766584
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

The regulatory effects of the autonomic nervous system (ANS) concern almost all organs which permanently feed information back to this global biological vigilance system controlling allostasis. Heart rate fluctuations are highly dependent on ANS control, making the heart one of the best indicators of ANS activity.

Low ANS activity level is associated with severe cardiac and cerebral events, as well as to death from any cause in the general population. It is even associated with sleep apnea/hypopnea.

Detailed Description

The main goal of this SYNAPSE study is to evaluate, on a selected prospective cohort of subjects aged 67 years upon study entry, the incidence of sleep apnea/hypopnea and the prognostic values of ANS activity levels measured at preset times and of cardiovascular or cerebrovascular events.

Study Timeline

• Study Start: 2003-01-15
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 852

Inclusion Criteria

• informed consent signed
• to participate in the PROOF study

Exclusion Criteria

• prior myocardiac infarction
• prior stroke
• hearth failure
• atrial fibrillation
• insulin-treated diabetes mellitus
• cardiac pacemaker
• disease limiting life expectancy to < 5 years
• contraindication to brain MRI
• living in an institution
• respiratory failure with oxygenotherapy
• sleep-related breathing disorders known and treated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events	During all the study

Secondary Outcome Measures

Name	Time	Method
Presence and relationship of sleep apnea/hypopnea and clinically silent stroke revealed through brain MRI	Years 1, 3, 5, 7 and 9

Trial Locations

Locations (1)

Centre Hospitalier de Saint-Etienne; 🇫🇷 Saint-Etienne, France