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Clinical Trials/NCT04775966
NCT04775966CompletedNot Applicable

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

University Hospital, Montpellier1 site in 1 country8,477 target enrollmentStarted: January 15, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
8,477
Locations
1
Primary Endpoint
Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Time Frame: 2020 versus 2019

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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