SYNAPSE: Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
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Outcome Measures
Primary Outcome Measures
- Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events [During all the study]
Secondary Outcome Measures
- Presence and relationship of sleep apnea/hypopnea and clinically silent stroke revealed through brain MRI [Years 1, 3, 5, 7 and 9]
Eligibility Criteria
Criteria
Inclusion Criteria:
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informed consent signed
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to participate in the PROOF study
Exclusion Criteria:
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prior myocardiac infarction
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prior stroke
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hearth failure
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atrial fibrillation
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insulin-treated diabetes mellitus
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cardiac pacemaker
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disease limiting life expectancy to < 5 years
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contraindication to brain MRI
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living in an institution
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respiratory failure with oxygenotherapy
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sleep-related breathing disorders known and treated
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
- Lavie P, Lavie L, Herer P. All-cause mortality in males with sleep apnoea syndrome: declining mortality rates with age. Eur Respir J. 2005 Mar;25(3):514-20.
- Marin JM, Carrizo SJ, Vicente E, Agusti AG. Long-term cardiovascular outcomes in men with obstructive sleep apnoea-hypopnoea with or without treatment with continuous positive airway pressure: an observational study. Lancet. 2005 Mar 19-25;365(9464):1046-53.
- Pitson DJ, Stradling JR. Autonomic markers of arousal during sleep in patients undergoing investigation for obstructive sleep apnoea, their relationship to EEG arousals, respiratory events and subjective sleepiness. J Sleep Res. 1998 Mar;7(1):53-9.
- Tsuji H, Venditti FJ Jr, Manders ES, Evans JC, Larson MG, Feldman CL, Levy D. Reduced heart rate variability and mortality risk in an elderly cohort. The Framingham Heart Study. Circulation. 1994 Aug;90(2):878-83.
- 0201085
- DGS 2003/0069