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Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea

Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea in a Prospective Cohort of Subjects Aged 67 Years

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00766584
Acronym
SYNAPSE
Enrollment
852
Registered
2008-10-06
Start date
2003-01-15
Completion date
2026-12-31
Last updated
2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Aging, Autonomic nervous system, stroke, Myocardiac infarction, Prospective cohort, Sleep apnea/hypopnea

Brief summary

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.

Interventions

OTHERSleep apnea/hypopnea detection

Simultaneous 24-hour ambulatory electrocardiogram and polygraphic recordings performed at home during a night.

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
67 Years to 68 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular eventsDuring all the study

Secondary

MeasureTime frame
Presence and relationship of sleep apnea/hypopnea and clinically silent stroke revealed through brain MRIYears 1, 3, 5, 7 and 9

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026