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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Recruiting

CT.gov ID

NCT04800341

Collaborator

(none)

500

Enrollment

Location

18.6

Anticipated Duration (Months)

26.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea	Other: Questionnaire

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.

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

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 12, 2021

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Prevalence of cardiovascular events [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 metabolic events [up to 15 years]
Prevalence of metabolic events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.
Prevalence of incident cancers [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 [up to 15 years]
Prevalence of deaths during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Secondary Outcome Measures

Effect of CPAP treatment on the cardiovascular events occurrence [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.
Effect of CPAP treatment on the metabolic events occurrence [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.
Effect of CPAP treatment on the incident cancers occurrence [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.