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

Collection of Medical Events Occurring During 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.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea
• Intervention / Treatment: 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.

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Jean-Louis PEPIN, MD; Phone Number: +33 476768473; Email: jpepin@chu-grenoble.fr
• Study Contact Backup: Name: Marie JOYEUX-FAURE, PharmD; Phone Number: +33 476767166; Email: mjoyeuxfaure@chu-grenoble.fr

Study Locations

• France
  • Grenoble, France, 38706
    • Recruiting
    • University Hospital Grenoble
    • Contact: Marie Joyeux-Faure, PharmD, PhDm; Email: mjoyeuxfaure@chu-grenoble.fr
    • Sub-Investigator: Renaud Tamisier, MD, PhD
    • Principal Investigator: Jean-Louis Pépin, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Sleep apnea patients included in the ESADA European database

Description

Inclusion Criteria:

• already included in the ESADA European database

Exclusion Criteria:

• refusal to participate

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Jean-Louis PEPIN, MD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2021
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Follow-up; Death; Sleep apnea; Cardiovascular event; Metabolic event; Incident cancer
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: 38RC20.369; 2020-A03030-39 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No