Subclinical Cardiovascular ImpairmentsINFRASASNCT01089257
Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome
An observational study of Subclinical Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome, run by University Hospital, Grenoble at 3 sites in France.
Trial summary
Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or functional precociously found among patients SAS? Secondary objectives: 1. Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Subclinical Cardiovascular Impairments, Obstructive Sleep Apnea Syndrome
- How many people
- 133 participants
- Where
- 3 sitesFrance
- Study dates
- Nov 2007to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index > 15)
Who may be able to join
- Male or female from 18 to 78 years old
- Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index > 15)
- ambulatory patients
- patients who have signed the inform consent form
- patients with health insurance
Who cannot join
- Body Mass Index upper or equal to 30
- cardiovascular pathology except blood pressure hypertension
- known or treated diabetes
- pathologies with consequence on blood pressure regulation
- drugs intakes with consequence on blood pressure regulation
- patient with chronic obstructive pulmonary disease
Show all 15Show fewer
- atrial fibrillation or more than 10/minute extrasystoles
- bedridden patients or patients with decreased mobility
- patients working at night or with shift work
- patients with carotid stenting or surgery history
- patients unable to sign the inform consent form
- patients already treated by cPAP or dental appliance for OSAS in the last 6 months
- pregnant or suckling female
- patients under supervision or trusteeship
- patients taking part in another clinical trial
Trial locations and contacts
3 sites in 1 country.
France3 sites
France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system
Clermont-Ferrand, 63000
France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory
Grenoble, 38000
France : Laboratoire EFCR - Functional cardiorespiratory explorations laboratory
Saint-Etienne, 42000
About this study
Official title: Subclinical Cardiovascular Impairments in Patients With Obstructive Sleep Apnea Syndrome
Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or functional precociously found among patients SAS? Secondary objectives:
- Which are the anthropometric parameters and/or of severity of SAS allowing to anticipate occurred of early of the cardiac function and/or rhythmic anomalies found among patients SAS?
- Do there exist biological markers who allow to anticipate the early vascular lesions or the anomalies beginners of the cardiac function?
- Which are the cardiovascular effects of a treatment of SAS by Continuous Positive Pressure (PC) after 3 to 6 months of treatment?
- Do the identified early cardiovascular attacks and/or the biological anomalies make it possible to predict occurred of cardiovascular events in this population of patients carrying SAS (followed longitudinal at 5 years)?
- Keywords
- Cardiovascular risks, Oxidative stress, Systemic inflammation, Endothelial function, Peripheral Arterial Tone, Positive Airway Pressure
- Medical subject headings
- Sleep Apnea, Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2010 (estimated)
- Study startNov 2007
- Primary completionNov 2012
- Study completionJun 2021
Why it stopped: Delayed inclusion at more than 14 years from the start of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Subclinical Cardiovascular ImpairmentsStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne, University Hospital, Clermont-Ferrand, Hôpital de la Croix-Rousse
- Responsible party
- Sponsor
- Investigators
- Jean-Louis JP PEPIN, ProfessorPhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01089257
- Sponsor's protocol ID
- 06PHR03
- Acronym
- INFRASAS
- Status last verified
- Dec 2025
- First submitted
- 16 Mar 2010
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lattimore JD, Celermajer DS, Wilcox I. Obstructive sleep apnea and cardiovascular disease. J Am Coll Cardiol. 2003 May 7;41(9):1429-37. doi: 10.1016/s0735-1097(03)00184-0.
PubMed 12742277Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.
PubMed 15301332Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. doi: 10.1001/jama.290.14.1906.
PubMed 14532320Marin 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.
PubMed 15781100Drager LF, Bortolotto LA, Lorenzi MC, Figueiredo AC, Krieger EM, Lorenzi-Filho G. Early signs of atherosclerosis in obstructive sleep apnea. Am J Respir Crit Care Med. 2005 Sep 1;172(5):613-8. doi: 10.1164/rccm.200503-340OC. Epub 2005 May 18.
PubMed 15901608Baguet JP, Boutin I, Barone-Rochette G, Levy P, Tamisier R, Pierre H, Boggetto-Graham L, Pepin JL. Hypertension diagnosis in obstructive sleep apnea: self or 24-hour ambulatory blood pressure monitoring? Int J Cardiol. 2013 Sep 1;167(5):2346-7. doi: 10.1016/j.ijcard.2012.11.037. Epub 2012 Nov 22. No abstract available.
PubMed 23176771Stanke-Labesque F, Pepin JL, de Jouvencel T, Arnaud C, Baguet JP, Petri MH, Tamisier R, Jourdil JF, Levy P, Back M. Leukotriene B4 pathway activation and atherosclerosis in obstructive sleep apnea. J Lipid Res. 2012 Sep;53(9):1944-51. doi: 10.1194/jlr.P022814. Epub 2012 Jul 3.
PubMed 22761257
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Cardiovascular Impairments in Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT01089257
- Acronym / sponsor ID
- INFRASAS / 06PHR03
- Keywords
- Cardiovascular risks, Oxidative stress, Systemic inflammation, Endothelial function, Peripheral Arterial Tone, Positive Airway Pressure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Delayed inclusion at more than 14 years from the start of the study
- Enrolment
- 133 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne, University Hospital, Clermont-Ferrand, Hôpital de la Croix-Rousse
- Study start
- Nov 2007 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 18 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or functional precociously found among patients SAS? Secondary objectives:
- Which are the anthropometric parameters and/or of severity of SAS allowing to anticipate occurred of early of the cardiac function and/or rhythmic anomalies found among patients SAS?
- Do there exist biological markers who allow to anticipate the early vascular lesions or the anomalies beginners of the cardiac function?
- Which are the cardiovascular effects of a treatment of SAS by Continuous Positive Pressure (PC) after 3 to 6 months of treatment?
- Do the identified early cardiovascular attacks and/or the biological anomalies make it possible to predict occurred of cardiovascular events in this population of patients carrying SAS (followed longitudinal at 5 years)?
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index > 15)
Key inclusion criteria (5 listed)
- Male or female from 18 to 78 years old
- Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index > 15)
- ambulatory patients
- patients who have signed the inform consent form
- patients with health insurance
Key exclusion criteria (15 listed)
- Body Mass Index upper or equal to 30
- cardiovascular pathology except blood pressure hypertension
- known or treated diabetes
- pathologies with consequence on blood pressure regulation
- drugs intakes with consequence on blood pressure regulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Delayed inclusion at more than 14 years from the start of the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 12742277Lattimore JD, Celermajer DS, Wilcox I. Obstructive sleep apnea and cardiovascular disease. J Am Coll Cardiol. 2003 May 7;41(9):1429-37. doi: 10.1016/s0735-1097(03)00184-0.
- Background: PubMed 15301332Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.
- Background: PubMed 14532320Shamsuzzaman AS, Gersh BJ, Somers VK. Obstructive sleep apnea: implications for cardiac and vascular disease. JAMA. 2003 Oct 8;290(14):1906-14. doi: 10.1001/jama.290.14.1906.
- Background: PubMed 15781100Marin 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.
- Background: PubMed 15901608Drager LF, Bortolotto LA, Lorenzi MC, Figueiredo AC, Krieger EM, Lorenzi-Filho G. Early signs of atherosclerosis in obstructive sleep apnea. Am J Respir Crit Care Med. 2005 Sep 1;172(5):613-8. doi: 10.1164/rccm.200503-340OC. Epub 2005 May 18.
- Results publication: PubMed 23176771Baguet JP, Boutin I, Barone-Rochette G, Levy P, Tamisier R, Pierre H, Boggetto-Graham L, Pepin JL. Hypertension diagnosis in obstructive sleep apnea: self or 24-hour ambulatory blood pressure monitoring? Int J Cardiol. 2013 Sep 1;167(5):2346-7. doi: 10.1016/j.ijcard.2012.11.037. Epub 2012 Nov 22. No abstract available.
- Derived from this study: PubMed 22761257Stanke-Labesque F, Pepin JL, de Jouvencel T, Arnaud C, Baguet JP, Petri MH, Tamisier R, Jourdil JF, Levy P, Back M. Leukotriene B4 pathway activation and atherosclerosis in obstructive sleep apnea. J Lipid Res. 2012 Sep;53(9):1944-51. doi: 10.1194/jlr.P022814. Epub 2012 Jul 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis JP PEPIN, ProfessorPhD principal investigator
University Hospital, Grenoble
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome, run by University Hospital, Grenoble at 3 sites 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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was stopped early (reason given: Delayed inclusion at more than 14 years from the start of the study). Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01089257, which also lists 7 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 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.