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

Completed

• Conditions: Sleep Apnea Syndromes

• Registration Number: NCT04775966
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2021-01-15
• Primary Completion: 2021-02-15
• Study Completion: 2021-02-15
• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-07
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8477

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days)	2020 versus 2019

Secondary Outcome Measures

Name	Time	Method
Change in the percentage of adherent patients (adherence > 4h/day/week) during the first lockdown versus corresponding 2019 weeks (h/days)	2020 versus 2019
Change in positive airway pressure(PAP)-adherence during the second lockdown versus corresponding 2019 weeks (h/days)	2020 versus 2019
Change in PAP-adherence 2020 versus 2019 (h/days/weeks)	2020 versus 2019
Change in patient adherence 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)	2020 versus 2019

Trial Locations

Locations (1)

Adene Group; 🇫🇷 Montpellier, France