Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea
This trial is active, not recruiting.
|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.
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 and 3
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
|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.|
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