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Long-Term Follow-up in Patients Included in the Meta-analysis Sleep Apnea Syndrome and Arterial Stiffness

Collection of Long-Term Follow-up Medical Events in Patients Included in the Meta-analysis Sleep Apnea Syndrome and Arterial Stiffness

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04704401
Acronym
PWV follow-up
Enrollment
321
Registered
2021-01-11
Start date
2021-01-13
Completion date
2022-08-29
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

Sleep apnea, Follow-up, Cardiovascular event, Metabolic event, incident cancer, Death

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.

Detailed description

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). The 9 studies were referred as : ADISAS (NCT011968), AGIRSASADOM (NCT010902), BPCO (NCT004044), BPCO-SAS (NCT01195064), DIAMETASAS, Aortic Dissection (NCT01068691), INFRASAS (NCT010892), VALSAS (NCT004094), NIV-OHS (NCT006030). The objective of this meta-analysis on individual data was to understand the relationship between the severity of the sleep apnea syndrome (measured by the apnea + hypopnea index) and arterial rigidity at the time of diagnosis of SAS. 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.

Interventions

OTHERQuestionnaire

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

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of cardiovascular eventsup to 15 yearsPrevalence of cardiovascular events during the follow-up of patients included in the meta-analysis sleep apnea syndrome and arterial stiffness, through a structured questionnaire.

Secondary

MeasureTime frameDescription
Prevalence of incident cancersup to 15 yearsPrevalence of incident cancers during the follow-up of patients included in the meta-analysis sleep apnea syndrome and arterial stiffness, through a structured questionnaire..
Prevalence of deathsup to 15 yearsPrevalence of deaths during the follow-up of patients included in the meta-analysis sleep apnea syndrome and arterial stiffness, through a structured questionnaire.
Prevalence of metabolic eventsup to 15 yearsPrevalence of metabolic events during the follow-up of patients included in the meta-analysis sleep apnea syndrome and arterial stiffness, through a structured questionnaire.
Effect of CPAP treatment on the metabolic events occurrenceduring 6 monthsMean CPAP observance (h/night) of patients included in the meta-analysis sleep apnea syndrome and arterial stiffness to determine its impact on the metabolic events occurrence.
Effect of CPAP treatment on the incident cancers occurrenceduring 6 monthsMean CPAP observance (h/night) of patients included in the meta-analysis sleep apnea syndrome and arterial stiffness to determine its impact on the incident cancers occurrence.
Effect of CPAP treatment on the cardiovascular events occurrenceduring 6 monthsMean CPAP observance (h/night) of patients included in the meta-analysis sleep apnea syndrome and arterial stiffness to determine its impact on the cardiovascular events occurrence.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026