Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04800341
Acronym
ESADAfollow-up
Enrollment
233
Registered
2021-03-16
Start date
2021-05-12
Completion date
2022-06-06
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 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.

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 80 Years

Inclusion criteria

* already included in the ESADA European database

Exclusion criteria

* refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of cardiovascular eventsup to 15 yearsPrevalence of cardiovascular events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.
Prevalence of metabolic eventsup to 15 yearsPrevalence of metabolic events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.
Prevalence of incident cancersup to 15 yearsPrevalence of incident cancers during the follow-up of patients included in the ESADA European database, through a structured questionnaire.
Prevalence of deathsup to 15 yearsPrevalence of deaths during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Secondary

MeasureTime frameDescription
Effect of CPAP treatment on the metabolic events occurrenceduring 6 monthsMean CPAP observance (h/night) of patients included in the ESADA European database 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 ESADA European database 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 ESADA European database to determine its impact on the cardiovascular events occurrence.

Countries

France

Outcome results

None listed

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