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

NCT04800341 | Completed

• 2 other identifiers: 38RC20.3692020-A03030-39
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Keywords

Sleep apnea; Follow-up; Cardiovascular event; Metabolic event; Incident cancer; Death

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Effect of CPAP treatment on the cardiovascular events occurrence

  during 6 months

• Effect of CPAP treatment on the metabolic events occurrence

  during 6 months

• Effect of CPAP treatment on the incident cancers occurrence

  during 6 months

Study Arms (1)

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

Interventions

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.

Patients ESADA follow-up

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sleep apnea patients included in the ESADA European database

You may qualify if:

• already included in the ESADA European database

You may not qualify if:

• refusal to participate

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital Grenoble

Grenoble, 38706, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Death

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jean-Louis PEPIN, MD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: March 16, 2021
• Study Start: May 12, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)