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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00766584
First received: October 3, 2008
Last updated: February 26, 2014
Last verified: February 2014

October 3, 2008
February 26, 2014
January 2003
December 2015   (final data collection date for primary outcome measure)
Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events [ Time Frame: During all the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00766584 on ClinicalTrials.gov Archive Site
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 ]
Presence and relationship of sleep apneas and clinically silent stroke revealed through brain MRI [ Time Frame: Years 1 and 3 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum

Non-Probability Sample

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

Healthy
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
PROOF cohort
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
Intervention: Other: Sleep apnea/hypopnea detection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
852
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
67 Years to 68 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00766584
0201085, DGS 2003/0069
No
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Principal Investigator: Jean-Claude BARTHELEMY, MD PhD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP