Sleep Apnea SyndromesCOVADENENCT04775966
CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic
An observational study of Sleep Apnea Syndromes, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The hypothesis of this work is that the COVID 19 pandemic and the associated lockdowns are likely to modify the adherence to positive airway pressure (PAP) treatments among patients with sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes
- How many people
- 8,477 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2021to 15 Feb 2021
- 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: Patients from the Adene group database treated with positive airway pressure (PAP) for sleep apnea in 2019 and 2020.
Who may be able to join
- patient treated/monitored by the Adene group
- treated for sleep apnea syndrome (i.e., an initial apnoea hypopnea index (iAHI) ≥ 30/h or iAHI ≥ 15/h (and more than 10/h respiratory-effort-related arousal or cardio-metabolic/respiratory comorbidities) associated with symptoms from among sleepiness, tiredness, snoring, headaches, hypertension, reduced vigilance, libido disorders, nocturia, choking or suffocation during sleep, daytime tiredness)
- Positive airway pressure (PAP)-treated for at least 4 months before January 1, 2019
- continuous PAP during 2019
- continuous PAP during 2020
- acceptance of PAP telemonitoring with consent given for data collection and data anonymization
Who cannot join
- less than 360 daily PAP tele-monitored data per year for 2019
- less than 360 daily PAP tele-monitored data per year for 2020
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis of this work is that the COVID 19 pandemic and the associated lockdowns are likely to modify the adherence to positive airway pressure (PAP) treatments among patients with sleep apnea. Identifying these patients and identifying adherence "trajectories" over time would help mobilize human and telemedicine resources on the patients most in need.
Read the detailed description
The primary objective of this study is to compare PAP adherence during lockdowns in 2020 with the corresponding weeks during 2019.
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep Apnea, Positive Airway Pressure, telemedicine, COVID 19
- Medical subject headings
- Sleep Apnea Syndromes, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The study population | Patients meeting eligibility criteria (see appropriate section). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days)
Measured: 2020 versus 2019
Secondary outcomes (5)
Change in positive airway pressure(PAP)-adherence during the second lockdown versus corresponding 2019 weeks (h/days)
Measured: 2020 versus 2019
Change in PAP-adherence 2020 versus 2019 (h/days/weeks)
Measured: 2020 versus 2019
Change in the percentage of adherent patients (adherence > 4h/day/week) during the first lockdown versus corresponding 2019 weeks (h/days)
Measured: 2020 versus 2019
Change in the percentage of adherent patients (adherence > 4h/day/week) during the second lockdown versus corresponding 2019 weeks (h/days)
Measured: 2020 versus 2019
Change in patient adherence 2020 versus 2019 (%).
Measured: 2020 versus 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start15 Jan 2021
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
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 Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 8,477 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dany Jaffuel, MD,PhD, Study director, Montpellier University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775966
- Sponsor's protocol ID
- RECHMPL21_0067
- Acronym
- COVADENE
- Status last verified
- Mar 2022
- First submitted
- 26 Feb 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertelli F, Suehs CM, Mallet JP, Court-Fortune I, Gagnadoux F, Borel JC, Gaubert O, Molinari N, Bourdin A, Jaffuel D. Did COVID-19 impact Positive Airway Pressure adherence in 2020? A cross-sectional study of 8477 patients with sleep apnea. Respir Res. 2022 Mar 4;23(1):46. doi: 10.1186/s12931-022-01969-z.
PubMed 35246109
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic
- ClinicalTrials.gov ID
- NCT04775966
- Acronym / sponsor ID
- COVADENE / RECHMPL21_0067
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep Apnea, Positive Airway Pressure, telemedicine, COVID 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,477 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 1 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 hypothesis of this work is that the COVID 19 pandemic and the associated lockdowns are likely to modify the adherence to positive airway pressure (PAP) treatments among patients with sleep apnea. Identifying these patients and identifying adherence "trajectories" over time would help mobilize human and telemedicine resources on the patients most in need.
Detailed description
The primary objective of this study is to compare PAP adherence during lockdowns in 2020 with the corresponding weeks during 2019.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | –Patients meeting eligibility criteria (see appropriate section). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the Adene group database treated with positive airway pressure (PAP) for sleep apnea in 2019 and 2020.
Key inclusion criteria (6 listed)
- patient treated/monitored by the Adene group
- treated for sleep apnea syndrome (i.e., an initial apnoea hypopnea index (iAHI) ≥ 30/h or iAHI ≥ 15/h (and more than 10/h respiratory-effort-related arousal or cardio-metabolic/respiratory comorbidities) associated with symptoms from among sleepiness, tiredness, snoring, headaches, hypertension, reduced vigilance, libido disorders, nocturia, choking or suffocation during sleep, daytime tiredness)
- Positive airway pressure (PAP)-treated for at least 4 months before January 1, 2019
- continuous PAP during 2019
- continuous PAP during 2020
Key exclusion criteria (2 listed)
- less than 360 daily PAP tele-monitored data per year for 2019
- less than 360 daily PAP tele-monitored data per year for 2020
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days)
Time frame: 2020 versus 2019
5 secondary outcomes
Change in positive airway pressure(PAP)-adherence during the second lockdown versus corresponding 2019 weeks (h/days)
Time frame: 2020 versus 2019
Change in PAP-adherence 2020 versus 2019 (h/days/weeks)
Time frame: 2020 versus 2019
Change in the percentage of adherent patients (adherence > 4h/day/week) during the first lockdown versus corresponding 2019 weeks (h/days)
Time frame: 2020 versus 2019
Change in the percentage of adherent patients (adherence > 4h/day/week) during the second lockdown versus corresponding 2019 weeks (h/days)
Time frame: 2020 versus 2019
Change in patient adherence 2020 versus 2019 (%).
Time frame: 2020 versus 2019
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 Mar 2022.
- Results publication: PubMed 35246109Bertelli F, Suehs CM, Mallet JP, Court-Fortune I, Gagnadoux F, Borel JC, Gaubert O, Molinari N, Bourdin A, Jaffuel D. Did COVID-19 impact Positive Airway Pressure adherence in 2020? A cross-sectional study of 8477 patients with sleep apnea. Respir Res. 2022 Mar 4;23(1):46. doi: 10.1186/s12931-022-01969-z.
- 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.
Dany Jaffuel, MD,PhD study director
Montpellier University Hospitals
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 Syndromes, run by University Hospital, Montpellier 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 6 inclusion and 2 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 Mar 2022. 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?
Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days) (time frame: 2020 versus 2019). 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 NCT04775966, 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 Mar 2022.