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Clinical Trials/NCT04800341
NCT04800341CompletedNot Applicable

Collection of Medical Events Occurring During Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

University Hospital, Grenoble1 site in 1 country233 target enrollmentStarted: May 12, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
233
Locations
1
Primary Endpoint
Prevalence of cardiovascular events

Study Overview

Brief Summary

The European database ESADA, containing data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome, prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective is to assess 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 European database ESADA prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation. A partnership agreement exists between University Hospital Grenoble (CHUGA) and ESADA for the reuse of CHUGA data. The data collected at CHUGA as part of the ESADA-Follow-up and outcomes questionnaire are also collected in the other European centers and will be centralized at the level of the coordinating center.

ESADA currently contains data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome. One of the main limitations of this cohort is the relatively limited amount of information concerning the long-term follow-up of the patients included in the registry.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective at the end of this data collection is to aggregate the follow-up data of more than 10,000 patients from all participating European centers to assess 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • already included in the ESADA European database

Exclusion Criteria

  • refusal to participate

Outcomes

Primary Outcomes

Prevalence of cardiovascular events

Time Frame: up to 15 years

Prevalence of cardiovascular events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of incident cancers

Time Frame: up to 15 years

Prevalence of incident cancers during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of deaths

Time Frame: up to 15 years

Prevalence of deaths during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of metabolic events

Time Frame: up to 15 years

Prevalence of metabolic events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Secondary Outcomes

  • Effect of CPAP treatment on the cardiovascular events occurrence(during 6 months)
  • Effect of CPAP treatment on the incident cancers occurrence(during 6 months)
  • Effect of CPAP treatment on the metabolic events occurrence(during 6 months)

Investigators

Sponsor
University Hospital, Grenoble
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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