Clinical trial NCT04800341: Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)
Official title: Collection of Medical Events Occurring During Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea
Keywords: Sleep apnea
Follow-up
Cardiovascular event
Metabolic event
Incident cancer
Death
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sleep apnea patients included in the ESADA European database

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.

Eligibility criteria: Inclusion Criteria:

* already included in the ESADA European database

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Prevalence of cardiovascular events
timeFrame: up to 15 years
measure: Prevalence of metabolic events
timeFrame: up to 15 years
measure: Prevalence of incident cancers
timeFrame: up to 15 years
measure: Prevalence of deaths
timeFrame: up to 15 years
Secondary outcomes:
measure: Effect of CPAP treatment on the cardiovascular events occurrence
timeFrame: during 6 months
measure: Effect of CPAP treatment on the metabolic events occurrence
timeFrame: during 6 months
measure: Effect of CPAP treatment on the incident cancers occurrence
timeFrame: during 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Louis PEPIN, MD
role: PRINCIPAL_INVESTIGATOR
References: