Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea "SYNAPSE"

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed 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.

Conditions

Interventions

  • Sleep apnea/hypopnea detection Other
    Other Names: HypnoPTT, Tyco Healthcare, USA
    Intervention Desc: Simultaneous 24-hour ambulatory electrocardiogram and polygraphic recordings performed at home during a night.
    ARM 1: Kind: Experimental
    Label: PROOF cohort
    Description: 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

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events During all the study No
Secondary Presence and relationship of sleep apnea/hypopnea and clinically silent stroke revealed through brain MRI Years 1 and 3 No

Biospecimen Retention:Samples Without DNA - Serum

Sponsors