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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00766584
First Posted: October 6, 2008
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
  Purpose

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 Intervention
Healthy Other: Sleep apnea/hypopnea detection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea in a Prospective Cohort of Subjects Aged 67 Years

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events [ Time Frame: During all the study ]

Secondary Outcome Measures:
  • 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
Serum

Enrollment: 852
Actual Study Start Date: January 15, 2003
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   67 Years to 68 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study 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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
Centre Hospitalier de Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Jean-Claude BARTHELEMY, MD PhD CHU de Saint-Etienne
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00766584     History of Changes
Other Study ID Numbers: 0201085
DGS 2003/0069
First Submitted: October 3, 2008
First Posted: October 6, 2008
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Aging
Autonomic nervous system
stroke
Myocardiac infarction
Prospective cohort
Sleep apnea/hypopnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases