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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sleep Apnea

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: already included in the ESADA European database Exclusion Criteria: refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients ESADA follow-up<br>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<br>* Structured questionnaire to collect cardiovascular and metabolic events, incident cancers and deaths that have occured, as weel as information on CPAP, through telephone interview.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular event, Metabolic event, Death, Sleep apnea, Follow-up, Incident cancer