Clinical trial NCT04704401: Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"
Official title: Collection of Long-Term Follow-up Medical Events in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea
Keywords: Sleep apnea
Follow-up
Cardiovascular event
Metabolic event
incident cancer
Death
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 893
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sleep apnea patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness"

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of cardiovascular events
timeFrame: up to 15 years
Secondary outcomes:
measure: Prevalence of metabolic events
timeFrame: up to 15 years
measure: Prevalence of incident cancers
timeFrame: up to 15 years
measure: Prevalence of deaths
timeFrame: up to 15 years
measure: Effect of CPAP treatment on the cardiovascular events occurrence
timeFrame: during 6 months
measure: Effect of CPAP treatment on the metabolic events occurrence
timeFrame: during 6 months
measure: Effect of CPAP treatment on the incident cancers occurrence
timeFrame: during 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis PEPIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.