Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT00766584

Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Healthy Apnea Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke Vascular Diseases

Age range

67 year–68 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Sleep apnea/hypopnea detection

Other

Simultaneous 24-hour ambulatory electrocardiogram and polygraphic recordings performed at home during a night.

Other names: HypnoPTT, Tyco Healthcare, USA

Primary outcomes

  1. Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events

    Time frame: During all the study

Secondary outcomes

  1. Presence and relationship of sleep apnea/hypopnea and clinically silent stroke revealed through brain MRI

    Time frame: Years 1, 3, 5, 7 and 9

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea in a Prospective Cohort of Subjects Aged 67 Years

Acronym: SYNAPSE

Important dates

Study start
2003
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2008
Registry last updated
Mar 18, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.