Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea

Healthy Clinical Trial

— SYNAPSE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00766584
• Other study ID #: 0201085
• Secondary ID: DGS 2003/0069
• Status: Active, not recruiting
• Start date: January 15, 2003
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 852
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 67 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Sleep Apnea Syndromes

Intervention

Other:
• Sleep apnea/hypopnea detection
Simultaneous 24-hour ambulatory electrocardiogram and polygraphic recordings performed at home during a night.

Locations

Country	Name	City	State
France	Centre Hospitalier de Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (6)

Barthelemy JC, Pichot V, Dauphinot V, Celle S, Laurent B, Garcin A, Maudoux D, Kerleroux J, Lacour JR, Kossovsky M, Gaspoz JM, Roche F. Autonomic nervous system activity and decline as prognostic indicators of cardiovascular and cerebrovascular events: th — View Citation

Celle S, Peyron R, Faillenot I, Pichot V, Alabdullah M, Gaspoz JM, Laurent B, Barthelemy JC, Roche F. Undiagnosed sleep-related breathing disorders are associated with focal brainstem atrophy in the elderly. Hum Brain Mapp. 2009 Jul;30(7):2090-7. doi: 10. — View Citation

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. doi: 10.1183/09031936.05.00051504. — View Citation

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. doi: 10.1016/S0140-6736(05)71141-7. — View Citation

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. doi: 10.1046/j.1365-2869.1998.00092.x. — View Citation

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. doi: 10.1161/01.cir.90.2.878. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events		During all the study
Secondary	Presence and relationship of sleep apnea/hypopnea and clinically silent stroke revealed through brain MRI		Years 1, 3, 5, 7 and 9