Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea (SYNAPSE)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea in a Prospective Cohort of Subjects Aged 67 Years|
- Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events [ Time Frame: During all the study ] [ Designated as safety issue: No ]
- Presence and relationship of sleep apnea/hypopnea and clinically silent stroke revealed through brain MRI [ Time Frame: Years 1 and 3 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
Other: Sleep apnea/hypopnea detection
Simultaneous 24-hour ambulatory electrocardiogram and polygraphic recordings performed at home during a night.
Other Name: HypnoPTT, Tyco Healthcare, USA
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00766584
|Centre Hospitalier de Saint-Etienne|
|Saint-Etienne, France, 42055|
|Principal Investigator:||Jean-Claude BARTHELEMY, MD PhD||CHU de Saint-Etienne|