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

Sleep Apnea Clinical Trial

— ESADAfollow-up  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04800341
• Other study ID #: 38RC20.369
• Secondary ID: 2020-A03030-39
• Status: Recruiting
• Start date: May 12, 2021
• Est. completion date: November 12, 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Grenoble
• Contact: Marie JOYEUX-FAURE, PharmD
• Phone: 476767166
• Email: mjoyeuxfaure[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 12, 2025
• Est. primary completion date: November 12, 2025
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• already included in the ESADA European database

Exclusion Criteria:

• refusal to participate

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of cardiovascular events	Prevalence of cardiovascular events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.	up to 15 years
Primary	Prevalence of metabolic events	Prevalence of metabolic events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.	up to 15 years
Primary	Prevalence of incident cancers	Prevalence of incident cancers during the follow-up of patients included in the ESADA European database, through a structured questionnaire.	up to 15 years
Primary	Prevalence of deaths	Prevalence of deaths during the follow-up of patients included in the ESADA European database, through a structured questionnaire.	up to 15 years
Secondary	Effect of CPAP treatment on the cardiovascular events occurrence	Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the cardiovascular events occurrence.	during 6 months
Secondary	Effect of CPAP treatment on the metabolic events occurrence	Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the metabolic events occurrence.	during 6 months
Secondary	Effect of CPAP treatment on the incident cancers occurrence	Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the incident cancers occurrence.	during 6 months