Autonomic Nervous System Activity, Aging and Sleep Apnea/Hypopnea - Full Text View

Sponsors and Collaborators:	Centre Hospitalier Universitaire de Saint Etienne Ministry of Health, France
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00766584

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

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Serum

Enrollment:	852
Study Start Date:	January 2003
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (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.

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

Ages Eligible for Study:	67 Years to 68 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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 of Results:

Barthélémy 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: the 'PROOF' Study. Study design and population sample. Associations with sleep-related breathing disorders: the 'SYNAPSE' Study. Neuroepidemiology. 2007;29(1-2):18-28.

Celle S, Peyron R, Faillenot I, Pichot V, Alabdullah M, Gaspoz JM, Laurent B, Barthélémy JC, Roche F. Undiagnosed sleep-related breathing disorders are associated with focal brainstem atrophy in the elderly. Hum Brain Mapp. 2008 Sep 9; [Epub ahead of print]

Other Publications:

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.

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.

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.

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.

Responsible Party:	CHU de Saint-Etienne ( Françoise LORCA )
Study ID Numbers:	0201085, DGS 2003/0069
Study First Received:	October 3, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00766584
Health Authority:	France: French Data Protection Authority; France: Ministry of Health

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

Aging
Autonomic nervous system
stroke

Myocardiac infarction
Prospective cohort
Sleep apnea/hypopnea

Study placed in the following topic categories:

Sleep Apnea Syndromes
Respiratory Tract Diseases
Cerebral Infarction
Apnea
Respiration Disorders
Stroke

Dyssomnias
Sleep Disorders
Healthy
Infarction
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009