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Completed

NCT Number: NCT04800341

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Grenoble

Grenoble, 38706, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • already included in the ESADA European database

Exclusion criteria

  • refusal to participate

Treatment and study plan

Questionnaire

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Effect of CPAP treatment on the cardiovascular events occurrence

    Time frame: during 6 months

    Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the cardiovascular events occurrence.

  2. Effect of CPAP treatment on the metabolic events occurrence

    Time frame: during 6 months

    Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the metabolic events occurrence.

  3. Effect of CPAP treatment on the incident cancers occurrence

    Time frame: during 6 months

    Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the incident cancers occurrence.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: ESADAfollow-up

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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