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

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:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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

Serum

Enrollment:	852
Study Start Date:	January 2003
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (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

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:

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]

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.

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

Sforza E, Gauthier M, Crawford-Achour E, Pichot V, Maudoux D, Barthélémy JC, Roche F. A 3-year longitudinal study of sleep disordered breathing in the elderly. Eur Respir J. 2012 Sep;40(3):665-72. doi: 10.1183/09031936.00133011. Epub 2012 Mar 9.

Tønnesen P, Lauri H, Perfekt R, Mann K, Batra A. Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial. Eur Respir J. 2012 Sep;40(3):548-54. doi: 10.1183/09031936.00155811. Epub 2012 Feb 9.

Sforza E, Chouchou F, Pichot V, Barthélémy JC, Roche F. Heart rate increment in the diagnosis of obstructive sleep apnoea in an older population. Sleep Med. 2012 Jan;13(1):21-8. Epub 2011 Nov 21.

Chouchou F, Sforza E, Celle S, Pichot V, Maudoux D, Garcin A, Barthélémy JC, Roche F; PROOF Study Group. Pulse transit time in screening sleep disordered breathing in an elderly population: the PROOF-SYNAPSE study. Sleep. 2011 Aug 1;34(8):1051-9.

Sforza E, Chouchou F, Collet P, Pichot V, Barthélémy JC, Roche F. Sex differences in obstructive sleep apnoea in an elderly French population. Eur Respir J. 2011 May;37(5):1137-43. Epub 2010 Sep 3.

Sforza E, Roche F, Thomas-Anterion C, Kerleroux J, Beauchet O, Celle S, Maudoux D, Pichot V, Laurent B, Barthélémy JC. Cognitive function and sleep related breathing disorders in a healthy elderly population: the SYNAPSE study. Sleep. 2010 Apr 1;33(4):515-21.

Guillot M, Costes F, Sforza E, Maudoux D, Bertoletti L, Barthélémy JC, Roche F. Is tidal expiratory flow limitation predictive of sleep-related disorders in the elderly? Eur Respir J. 2010 Oct;36(4):842-8. Epub 2010 Apr 8.

Responsible Party:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00766584 History of Changes
Other Study ID Numbers:	0201085, DGS 2003/0069
Study First Received:	October 3, 2008
Last Updated:	February 12, 2013
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

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases

Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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