CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic | NCT04775966

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

NCT04775966

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Mar 22, 2022Actual

Enrollment

8,477Actual

Phase

Not provided

Conditions

Sleep Apnea Syndromes

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2021Actual

Primary Completion Date

Feb 15, 2021Actual

Completion Date

Feb 15, 2021Actual

First Submitted Date

Feb 26, 2021

First Submission Date that Met QC Criteria

Feb 26, 2021

First Posted Date

Mar 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2022

Last Update Posted Date

Mar 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8,477Actual

Label	Type	Description	Intervention Names
The study population		Patients meeting eligibility criteria (see appropriate section).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days)		2020 versus 2019

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients from the Adene group database treated with positive airway pressure (PAP) for sleep apnea in 2019 and 2020.

Sampling Method

Probability Sample

Name	Affiliation	Role
Dany Jaffuel, MD,PhD	Montpellier University Hospitals	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35246109	Result	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.

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic