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OpenTrials
Completed

NCT Number: NCT04775966

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

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea COVID-19 Coronaviridae Infections Coronavirus Infections Dyssomnias Infections Lung Diseases Nervous System Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Sleep Disorders, Intrinsic Sleep Wake Disorders Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adene Group

Montpellier, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 2020 versus 2019

Secondary outcomes

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

    Time frame: 2020 versus 2019

  2. Change in PAP-adherence 2020 versus 2019 (h/days/weeks)

    Time frame: 2020 versus 2019

  3. 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

  4. 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

  5. Change in patient adherence 2020 versus 2019 (%).

    Time frame: 2020 versus 2019

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: COVADENE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 1, 2021
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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