Clinical trial NCT04775966: CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic
Official title: CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndromes
Keywords: Sleep Apnea
Positive Airway Pressure
telemedicine
COVID 19
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 8477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days)
timeFrame: 2020 versus 2019
Secondary outcomes:
measure: Change in positive airway pressure(PAP)-adherence during the second lockdown versus corresponding 2019 weeks (h/days)
timeFrame: 2020 versus 2019
measure: Change in PAP-adherence 2020 versus 2019 (h/days/weeks)
timeFrame: 2020 versus 2019
measure: Change in the percentage of adherent patients (adherence > 4h/day/week) during the first lockdown versus corresponding 2019 weeks (h/days)
timeFrame: 2020 versus 2019
measure: Change in the percentage of adherent patients (adherence > 4h/day/week) during the second lockdown versus corresponding 2019 weeks (h/days)
timeFrame: 2020 versus 2019
measure: Change in patient adherence 2020 versus 2019 (%).
timeFrame: 2020 versus 2019
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Adene Group
Study officials:
affiliation: Montpellier University Hospitals
name: Dany Jaffuel, MD,PhD
role: STUDY_DIRECTOR
References:
citation: 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.