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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04775966
Recruitment Status : Completed
First Posted : March 1, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Sleep Apnea Syndromes

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

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Study Type : Observational
Actual Enrollment : 8477 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic
Actual Study Start Date : January 15, 2021
Actual Primary Completion Date : February 15, 2021
Actual Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort
The study population
Patients meeting eligibility criteria (see appropriate section).



Primary Outcome Measures :
  1. Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days) [ Time Frame: 2020 versus 2019 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775966


Locations
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France
Adene Group
Montpellier, France
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Dany Jaffuel, MD,PhD Montpellier University Hospitals
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04775966    
Other Study ID Numbers: RECHMPL21_0067
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Sleep Apnea
Positive Airway Pressure
telemedicine
COVID 19
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases