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

NCT ID: NCT04775966

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8477 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-15

Study Completion Date

2021-02-15

Brief Summary

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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

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

Conditions

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Sleep Apnea Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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The study population

Patients meeting eligibility criteria (see appropriate section).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dany Jaffuel, MD,PhD

Role: STUDY_DIRECTOR

Montpellier University Hospitals

Locations

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Adene Group

Montpellier, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 35246109 (View on PubMed)

Other Identifiers

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RECHMPL21_0067

Identifier Type: -

Identifier Source: org_study_id

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