CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic (COVADENE)

March 7, 2022 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Completed

Conditions

Detailed Description

The primary objective of this study is to compare PAP adherence during lockdowns in 2020 with the corresponding weeks during 2019.

Study Type

Observational

Enrollment (Actual)

8477

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France
        • Adene Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients from the Adene group database treated with positive airway pressure (PAP) for sleep apnea in 2019 and 2020.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • less than 360 daily PAP tele-monitored data per year for 2019
  • less than 360 daily PAP tele-monitored data per year for 2020

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
The study population
Patients meeting eligibility criteria (see appropriate section).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days)
Time Frame: 2020 versus 2019
2020 versus 2019

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in positive airway pressure(PAP)-adherence during the second lockdown versus corresponding 2019 weeks (h/days)
Time Frame: 2020 versus 2019
2020 versus 2019
Change in PAP-adherence 2020 versus 2019 (h/days/weeks)
Time Frame: 2020 versus 2019
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
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
2020 versus 2019
Change in patient adherence 2020 versus 2019 (%).
Time Frame: 2020 versus 2019
2020 versus 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Dany Jaffuel, MD,PhD, Montpellier University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Actual)

February 15, 2021

Study Completion (Actual)

February 15, 2021

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL21_0067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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