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NCT04775966 Clinical Trial

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

Sleep Apnea Syndromes Clinical Trial

— COVADENE  

Official title:
CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04775966
Other study ID # RECHMPL21_0067
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 15, 2021
Est. completion date February 15, 2021

Study information
Verified date March 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Identifying these patients and identifying adherence "trajectories" over time would help mobilize human and telemedicine resources on the patients most in need.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 8477
Est. completion date February 15, 2021
Est. primary completion date February 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Adene Group Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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. 20 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days) 2020 versus 2019
Secondary Change in positive airway pressure(PAP)-adherence during the second lockdown versus corresponding 2019 weeks (h/days) 2020 versus 2019
Secondary Change in PAP-adherence 2020 versus 2019 (h/days/weeks) 2020 versus 2019
Secondary Change in the percentage of adherent patients (adherence > 4h/day/week) during the first lockdown versus corresponding 2019 weeks (h/days) 2020 versus 2019
Secondary Change in the percentage of adherent patients (adherence > 4h/day/week) during the second lockdown versus corresponding 2019 weeks (h/days) 2020 versus 2019
Secondary Change in patient adherence 2020 versus 2019 (%). 2020 versus 2019
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