Cardiovascular Impairments and Obstructive Sleep Apnea Sy... | NCT01089257

Studies
Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome

NCT01089257

Sponsor

University Hospital, Grenoble

Status

Terminated

Last Update Posted

Dec 29, 2025Actual

Enrollment

133Actual

Phase

Not provided

Conditions

Subclinical Cardiovascular Impairments
Obstructive Sleep Apnea Syndrome

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Delayed inclusion at more than 14 years from the start of the study

Expanded Access Info

Start Date

Nov 2007Actual

Primary Completion Date

Nov 2012Actual

Completion Date

Jun 2021Actual

First Submitted Date

Mar 16, 2010

First Submission Date that Met QC Criteria

Mar 16, 2010

First Posted Date

Mar 18, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2025

Last Update Posted Date

Dec 29, 2025Actual

Name	Class
Centre Hospitalier Universitaire de Saint Etienne	OTHER
University Hospital, Clermont-Ferrand	OTHER
Hôpital de la Croix-Rousse	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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)?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

133Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

78 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index > 15)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Louis JP PEPIN, ProfessorPhD	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
France : Laboratoire d'explorations fonctionnelles du système nerveux - Functional explorations laboratory of nervous system		Clermont-Ferrand		63000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12742277	Background	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.
15301332	Background	Parish JM, Somers VK. Obstructive sleep apnea and cardiovascular disease. Mayo Clin Proc. 2004 Aug;79(8):1036-46. doi: 10.4065/79.8.1036.

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases