This trial is active, not recruiting.

Condition healthy
Treatment sleep apnea/hypopnea detection
Sponsor Centre Hospitalier Universitaire de Saint Etienne
Collaborator Ministry of Health, France
Start date January 2003
End date December 2021
Trial size 852 participants
Trial identifier NCT00766584, 0201085, DGS 2003/0069


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
This cohort is the same than the PROOF study (NCT00759304). Subjects were recruited amongst the inhabitants of the city of Saint-Etienne, France, and were eligible if aged 65 at the inclusion date in the PROOF study
sleep apnea/hypopnea detection HypnoPTT, Tyco Healthcare, USA
Simultaneous 24-hour ambulatory electrocardiogram and polygraphic recordings performed at home during a night.

Primary Outcomes

Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events
time frame: During all the study

Secondary Outcomes

Presence and relationship of sleep apnea/hypopnea and clinically silent stroke revealed through brain MRI
time frame: Years 1 and 3

Eligibility Criteria

Male or female participants from 67 years up to 68 years old.

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

Additional Information

Official title Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea in a Prospective Cohort of Subjects Aged 67 Years
Principal investigator Jean-Claude BARTHELEMY, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Saint Etienne.