NCT04775966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,477

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1 month

First QC Date

February 26, 2021

Last Update Submit

March 7, 2022

Conditions

Sleep Apnea Syndromes

Keywords

Sleep ApneaPositive Airway PressuretelemedicineCOVID 19

Outcome Measures

Primary Outcomes (1)

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

    2020 versus 2019

Secondary Outcomes (5)

  • 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

  • Change in the percentage of adherent patients (adherence > 4h/day/week) during the first lockdown versus corresponding 2019 weeks (h/days)

    2020 versus 2019

  • Change in the percentage of adherent patients (adherence > 4h/day/week) during the second lockdown versus corresponding 2019 weeks (h/days)

    2020 versus 2019

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

    2020 versus 2019

Study Arms (1)

The study population

Patients meeting eligibility criteria (see appropriate section).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • less than 360 daily PAP tele-monitored data per year for 2019
  • less than 360 daily PAP tele-monitored data per year for 2020

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adene Group

Montpellier, France

Location

Related Publications (1)

  • 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.

    PMID: 35246109RESULT

MeSH Terms

Conditions

Sleep Apnea SyndromesCOVID-19

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung Diseases

Study Officials

  • Dany Jaffuel, MD,PhD

    Montpellier University Hospitals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 1, 2021

Study Start

January 15, 2021

Primary Completion

February 15, 2021

Study Completion

February 15, 2021

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)