NCT04704401

Brief Summary

The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV). Currently, we do not have long-term follow-up data for these patients. The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire. Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

January 13, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2022

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

December 7, 2020

Last Update Submit

December 15, 2025

Conditions

Sleep Apnea

Keywords

Sleep apneaFollow-upCardiovascular eventMetabolic eventincident cancerDeath

Outcome Measures

Primary Outcomes (1)

  • Prevalence of cardiovascular events

    Prevalence of cardiovascular events during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.

    up to 15 years

Secondary Outcomes (6)

  • Prevalence of metabolic events

    up to 15 years

  • Prevalence of incident cancers

    up to 15 years

  • Prevalence of deaths

    up to 15 years

  • Effect of CPAP treatment on the cardiovascular events occurrence

    during 6 months

  • Effect of CPAP treatment on the metabolic events occurrence

    during 6 months

  • +1 more secondary outcomes

Study Arms (1)

Patients PWV follow-up

Patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" and contacted by phone for the collection of cardiovascular and metabolic events, incident cancers and deaths, through a structured questionnaire.

Other: Questionnaire

Interventions

QuestionnaireOTHER

Structured questionnaire to collect cardiovascular and metabolic events, incident cancers and deaths that have occured, as weel as information on CPAP, through telephone interview.

Patients PWV follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sleep apnea patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness"

You may qualify if:

  • already included in the meta-analysis "sleep apnea syndrome and arterial stiffness".

You may not qualify if:

  • refusal to participate
  • family not reachable and death not identified in the Hospital medical base
  • persons under judicial protection (article L1122-2 of the Public Health Code) and patients under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, 38706, France

Location

Related Publications (1)

  • Bironneau V, Tamisier R, Trzepizur W, Andriantsitohaina R, Berger M, Goupil F, Joyeux-Faure M, Jullian-Desayes I, Launois S, Le Vaillant M, Martinez MC, Roche F, Pepin JL, Gagnadoux F. Sleep apnoea and endothelial dysfunction: An individual patient data meta-analysis. Sleep Med Rev. 2020 Aug;52:101309. doi: 10.1016/j.smrv.2020.101309. Epub 2020 Mar 13.

    PMID: 32234658BACKGROUND

MeSH Terms

Conditions

Sleep Apnea SyndromesDeath

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jean-Louis PEPIN, MD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2020

First Posted

January 11, 2021

Study Start

January 13, 2021

Primary Completion

August 29, 2022

Study Completion

August 29, 2022

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)