Sleep ApneaPWV follow-upNCT04704401
Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"
An observational study of Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Questionnaire
- How many people
- 321 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2021to 29 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sleep apnea patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness"
Who may be able to join
- already included in the meta-analysis "sleep apnea syndrome and arterial stiffness".
Who cannot join
- refusal to participate
- family not reachable and death not identified in the Hospital medical base
- persons under judicial protection (article L1122-2 of the Public Health Code) and patients under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collection of Long-Term Follow-up Medical Events in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"
The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).
Currently, we do not have long-term follow-up data for these patients.
Read more
The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.
Others secondary objectives are to evaluate 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 meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).
The 9 studies were referred as : ADISAS (NCT011968), AGIRSASADOM (NCT010902), BPCO (NCT004044), BPCO-SAS (NCT01195064), DIAMETASAS, Aortic Dissection (NCT01068691), INFRASAS (NCT010892), VALSAS (NCT004094), NIV-OHS (NCT006030).
The objective of this meta-analysis on individual data was to understand the relationship between the severity of the sleep apnea syndrome (measured by the apnea + hypopnea index) and arterial rigidity at the time of diagnosis of SAS.
Currently, we do not have long-term follow-up data for these patients.
The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.
Others secondary objectives are to evaluate 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 PWV follow-up | Patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" 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 meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.
Measured: up to 15 years
Secondary outcomes (6)
Prevalence of metabolic events
Prevalence of metabolic events during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", 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 meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire..
Measured: up to 15 years
Prevalence of deaths
Prevalence of deaths during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.
Measured: up to 15 years
Effect of CPAP treatment on the cardiovascular events occurrence
Mean CPAP observance (h/night) of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" 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 meta-analysis "sleep apnea syndrome and arterial stiffness" 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 meta-analysis "sleep apnea syndrome and arterial stiffness" 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 posted11 Jan 2021
- Study start13 Jan 2021
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
Why it stopped: recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 321 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
- NCT04704401
- Sponsor's protocol ID
- 38RC20.373
- Other IDs
- 2020-A03065-34
- Acronym
- PWV follow-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
Publications
Bironneau V, Tamisier R, Trzepizur W, Andriantsitohaina R, Berger M, Goupil F, Joyeux-Faure M, Jullian-Desayes I, Launois S, Le Vaillant M, Martinez MC, Roche F, Pepin JL, Gagnadoux F. Sleep apnoea and endothelial dysfunction: An individual patient data meta-analysis. Sleep Med Rev. 2020 Aug;52:101309. doi: 10.1016/j.smrv.2020.101309. Epub 2020 Mar 13.
PubMed 32234658
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 Long-Term Follow-up Medical Events in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"
- ClinicalTrials.gov ID
- NCT04704401
- Acronym / sponsor ID
- PWV follow-up / 38RC20.373
- Conditions
- Sleep Apnea
- Keywords
- Sleep apnea, Follow-up, Cardiovascular event, Metabolic event, incident cancer, Death
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulty
- Enrolment
- 321 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 11 Jan 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 meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).
Currently, we do not have long-term follow-up data for these patients.
The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.
Others secondary objectives are to evaluate 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 meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).
The 9 studies were referred as : ADISAS (NCT011968), AGIRSASADOM (NCT010902), BPCO (NCT004044), BPCO-SAS (NCT01195064), DIAMETASAS, Aortic Dissection (NCT01068691), INFRASAS (NCT010892), VALSAS (NCT004094), NIV-OHS (NCT006030).
The objective of this meta-analysis on individual data was to understand the relationship between the severity of the sleep apnea syndrome (measured by the apnea + hypopnea index) and arterial rigidity at the time of diagnosis of SAS.
Currently, we do not have long-term follow-up data for these patients.
The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.
Others secondary objectives are to evaluate 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 PWV follow-up | – | Other: QuestionnairePatients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" 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 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sleep apnea patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness"
Key inclusion criteria (1 listed)
- already included in the meta-analysis "sleep apnea syndrome and arterial stiffness".
Key exclusion criteria (3 listed)
- refusal to participate
- family not reachable and death not identified in the Hospital medical base
- persons under judicial protection (article L1122-2 of the Public Health Code) and patients under guardianship or curatorship
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 PWV 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 meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.
6 secondary outcomes
Prevalence of metabolic events
Time frame: up to 15 years
Prevalence of incident cancers
Time frame: up to 15 years
Prevalence of deaths
Time frame: up to 15 years
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 was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Background: PubMed 32234658Bironneau V, Tamisier R, Trzepizur W, Andriantsitohaina R, Berger M, Goupil F, Joyeux-Faure M, Jullian-Desayes I, Launois S, Le Vaillant M, Martinez MC, Roche F, Pepin JL, Gagnadoux F. Sleep apnoea and endothelial dysfunction: An individual patient data meta-analysis. Sleep Med Rev. 2020 Aug;52:101309. doi: 10.1016/j.smrv.2020.101309. Epub 2020 Mar 13.
- 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 3 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: stopped early, 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 was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04704401, which also lists 1 linked publication.
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.