Sleep ApneaESADAfollow-upNCT04800341
Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)
An observational study of Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
Trial 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/). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Questionnaire
- How many people
- 233 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2021to 6 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Sleep apnea patients included in the ESADA European database
Who may be able to join
- already included in the ESADA European database
Who cannot join
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Apnea
- Being tested
- Questionnaire
- Keywords
- Sleep apnea, Follow-up, Cardiovascular event, Metabolic event, Incident cancer, Death
- Medical subject headings
- Sleep Apnea Syndromes, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Structured questionnaire to collect cardiovascular and metabolic events, incident cancers and deaths that have occured, as weel as information on CPAP, through telephone interview.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cardiovascular events
Prevalence of cardiovascular events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 15 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start12 May 2021
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis PEPIN, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800341
- Sponsor's protocol ID
- 38RC20.369
- Other IDs
- 2020-A03030-39
- Acronym
- ESADAfollow-up
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2020
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Medical Events Occurring During Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)
- ClinicalTrials.gov ID
- NCT04800341
- Acronym / sponsor ID
- ESADAfollow-up / 38RC20.369
- Conditions
- Sleep Apnea
- Keywords
- Sleep apnea, Follow-up, Cardiovascular event, Metabolic event, Incident cancer, Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients ESADA follow-up | – | Other: QuestionnairePatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Sleep apnea patients included in the ESADA European database
Key inclusion criteria (1 listed)
- already included in the ESADA European database
Key exclusion criteria (1 listed)
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireStructured questionnaire to collect cardiovascular and metabolic events, incident cancers and deaths that have occured, as weel as information on CPAP, through telephone interview. | Other | Patients ESADA follow-up |
Primary outcome
Prevalence of cardiovascular events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 15 years
Prevalence of deaths during the follow-up of patients included in the ESADA European database, through a structured questionnaire.
3 secondary outcomes
Effect of CPAP treatment on the cardiovascular events occurrence
Time frame: during 6 months
Effect of CPAP treatment on the metabolic events occurrence
Time frame: during 6 months
Effect of CPAP treatment on the incident cancers occurrence
Time frame: during 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis PEPIN, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of cardiovascular events (time frame: up to 15 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.