Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea (SYNAPSE)
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|ClinicalTrials.gov Identifier: NCT00766584|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2008
Last Update Posted : June 21, 2019
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.
|Condition or disease||Intervention/treatment|
|Healthy||Other: Sleep apnea/hypopnea detection|
|Study Type :||Observational|
|Actual Enrollment :||852 participants|
|Official Title:||Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea in a Prospective Cohort of Subjects Aged 67 Years|
|Actual Study Start Date :||January 15, 2003|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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
- Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events [ Time Frame: During all the study ]
- Presence and relationship of sleep apnea/hypopnea and clinically silent stroke revealed through brain MRI [ Time Frame: Years 1, 3, 5, 7 and 9 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00766584
|Centre Hospitalier de Saint-Etienne|
|Saint-Etienne, France, 42055|
|Principal Investigator:||Jean-Claude BARTHELEMY, MD PhD||CHU de Saint-Etienne|