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Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

NCT ID: NCT04800341

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

233 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-12

Study Completion Date

2022-06-06

Brief Summary

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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

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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.

Conditions

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Sleep Apnea

Keywords

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Sleep apnea Follow-up Cardiovascular event Metabolic event Incident cancer Death

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients ESADA follow-up

Patients included in the ESADA European database and contacted by phone for the collection of cardiovascular and metabolic events, incident cancers and deaths, through a structured questionnaire.

Questionnaire

Intervention Type OTHER

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

Interventions

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Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* already included in the ESADA European database

Exclusion Criteria

* refusal to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Louis PEPIN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital Grenoble

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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2020-A03030-39

Identifier Type: OTHER

Identifier Source: secondary_id

38RC20.369

Identifier Type: -

Identifier Source: org_study_id