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AzTrials

HealthyPROOFNCT00759304

Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events

An observational study of Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 65 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
1,011 participants
Where
1 siteFrance
Study dates
2 Jan 2000to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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.

Who may be able to join

  • 65 years old
  • informed consent signed

Who cannot join

  • prior myocardiac infarction
  • prior stroke
  • hearth failure
  • atrial fibrillation
  • insulin-treated diabetes mellitus
  • cardiac pacemaker
Show all 9Show fewer
  • disease limiting life expectancy to < 5 years
  • contraindication to brain MRI
  • living in an institution

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier de Saint-Etienne

    Saint-Etienne, 42055

Other trials in France

About this study

Official title: Evaluation of Aging, Autonomic Nervous System Activity and Cardiovascular Events on a Prospective Cohort of Subjects Aged 65 Years

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.

This PROOF study was hence designed to evaluate ANS activity levels among a healthy retired population, but should these levels decline overtime, to use this as a predictor of cardiovascular and cerebrovascular events, taking into account established cardiovascular risk factors.

Read the detailed description

The main goal of this PROOF study is to evaluate, on a selected prospective cohort of subjects aged 65 years upon study entry, the prognostic values of ANS activity levels measured at preset times, and more specifically, of its decline over the follow-up period, for fatal and non-fatal cardiovascular and cerebrovascular events.

Conditions
Healthy
Keywords
Aging, cardiovascular risk factors, Autonomic nervous system, stroke, Myocardiac infarction, Neuropsychological evaluation, Prospective cohort
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00759304
Study groupRoleWhat they receive
PROOF cohortHealthy inhabitants of the city of Saint-Etienne, France, and aged 65 years at the inclusion date.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events

    Measured: During all the study

Secondary outcomes (4)

  1. Presence and severity of clinically silent stroke revealed through brain MRI

    Measured: Years 1, 3 and 5

  2. Neuropsychological performance

    Measured: Years 1, 3 and 5

  3. ANS activity measured by heart rate variability + spontaneous baroreflex + blood pressure variability

    Measured: Years 1, 3 and 5

  4. Biological data : fasting blood glucose, total and HDL cholesterol, triglycerides and CRP

    Measured: Years 1, 3 and 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2008 (estimated)
  2. Study start2 Jan 2000
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,011 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00759304
Sponsor's protocol ID
9808112
Acronym
PROOF
Status last verified
Apr 2025
First submitted
24 Sep 2008
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roche F, Gaspoz JM, Da Costa A, Isaaz K, Duverney D, Pichot V, Costes F, Lacour JR, Barthelemy JC. Frequent and prolonged asymptomatic episodes of paroxysmal atrial fibrillation revealed by automatic long-term event recorders in patients with a negative 24-hour Holter. Pacing Clin Electrophysiol. 2002 Nov;25(11):1587-93. doi: 10.1046/j.1460-9592.2002.01587.x.

    PubMed 12494616

  • Pichot V, Buffiere S, Gaspoz JM, Costes F, Molliex S, Duverney D, Roche F, Barthelemy JC. Wavelet transform of heart rate variability to assess autonomic nervous system activity does not predict arousal from general anesthesia. Can J Anaesth. 2001 Oct;48(9):859-63. doi: 10.1007/BF03017350.

    PubMed 11606341

  • 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: the 'PROOF' Study. Study design and population sample. Associations with sleep-related breathing disorders: the 'SYNAPSE' Study. Neuroepidemiology. 2007;29(1-2):18-28. doi: 10.1159/000108914.

    PubMed 17898520

  • Gosse P, Roche F, Dauphinot V, Maudoux D, Pichot V, Barthelemy JC. Components of arterial stiffness in a population of 65-year-old subjects: PROOF study. J Hypertens. 2008 Jun;26(6):1138-46. doi: 10.1097/HJH.0b013e3282fa142b.

    PubMed 18475151

  • Rouch I, Anterion CT, Dauphinot V, Kerleroux J, Roche F, Barthelemy JC, Laurent B. Cognitive complaints, neuropsychological performance and affective disorders in elderly community residents. Disabil Rehabil. 2008;30(23):1794-802. doi: 10.1080/09638280701667825.

    PubMed 18608410

  • Vogrig M, Berger AE, Bourlet T, Waeckel L, Haccourt A, Chanavat A, Hupin D, Roche F, Botelho-Nevers E, Pozzetto B, Paul S. Monitoring of Both Humoral and Cellular Immunities Could Early Predict COVID-19 Vaccine Efficacy Against the Different SARS-CoV2 Variants. J Clin Immunol. 2023 Jan;43(1):31-45. doi: 10.1007/s10875-022-01354-x. Epub 2022 Aug 25.

    PubMed 36006568

  • Hupin D, Raffin J, Barth N, Berger M, Garet M, Stampone K, Celle S, Pichot V, Bongue B, Barthelemy JC, Roche F. Even a Previous Light-Active Physical Activity at Work Still Reduces Late Myocardial Infarction and Stroke in Retired Adults Aged>65 Years by 32%: The PROOF Cohort Study. Front Public Health. 2019 Mar 19;7:51. doi: 10.3389/fpubh.2019.00051. eCollection 2019.

    PubMed 30941340

  • Sforza E, Millasseau S, Hupin D, Barthelemy JC, Roche F. Arterial stiffness alteration and obstructive sleep apnea in an elderly cohort free of cardiovascular event history: the PROOF cohort study. Sleep Breath. 2019 Mar;23(1):201-208. doi: 10.1007/s11325-018-1683-x. Epub 2018 Jun 26.

    PubMed 29946946

  • Celle S, Boutet C, Annweiler C, Barthelemy JC, Roche F. Sleep apnoea in the asymptomatic elderly: a real issue for the brain? Eur Respir J. 2018 Jun 14;51(6):1702450. doi: 10.1183/13993003.02450-2017. Print 2018 Jun.

    PubMed 29903827

  • Monneret D, Barthelemy JC, Hupin D, Maudoux D, Celle S, Sforza E, Roche F. Serum lipid profile, sleep-disordered breathing and blood pressure in the elderly: a 10-year follow-up of the PROOF-SYNAPSE cohort. Sleep Med. 2017 Nov;39:14-22. doi: 10.1016/j.sleep.2017.07.028. Epub 2017 Sep 18.

    PubMed 29157582

  • Saint Martin M, Labeix P, Garet M, Thomas T, Barthelemy JC, Collet P, Roche F, Sforza E. Does Subjective Sleep Affect Bone Mineral Density in Older People with Minimal Health Disorders? The PROOF Cohort. J Clin Sleep Med. 2016 Nov 15;12(11):1461-1469. doi: 10.5664/jcsm.6266.

    PubMed 27655463

  • Sforza E, Saint Martin M, Thomas T, Collet P, Garet M, Barthelemy JC, Roche F. Risk factors of osteoporosis in healthy elderly with unrecognized obstructive sleep apnea: role of physical activity. Sleep Med. 2016 Jun;22:25-32. doi: 10.1016/j.sleep.2016.04.010. Epub 2016 Jun 7.

    PubMed 27544832

  • Sforza E, Saint Martin M, Barthelemy JC, Roche F. Mood disorders in healthy elderly with obstructive sleep apnea: a gender effect. Sleep Med. 2016 Mar;19:57-62. doi: 10.1016/j.sleep.2015.11.007. Epub 2015 Nov 25.

    PubMed 27198948

  • Boutet C, Vassal F, Celle S, Schneider FC, Barthelemy JC, Laurent B, Barral FG, Roche F. Incidental findings on brain magnetic resonance imaging in the elderly:the PROOF study. Brain Imaging Behav. 2017 Feb;11(1):293-299. doi: 10.1007/s11682-016-9519-4.

    PubMed 26843003

  • Sforza E, Celle S, Saint-Martin M, Barthelemy JC, Roche F. Hippocampus volume and subjective sleepiness in older people with sleep-disordered breathing: a preliminary report. J Sleep Res. 2016 Apr;25(2):190-3. doi: 10.1111/jsr.12367. Epub 2015 Dec 14.

    PubMed 26662175

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite criterion : fatal and non-fatal cardiovascular or cerebrovascular events (time frame: During all the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00759304, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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