NCT05385302

Brief Summary

Multicentric, prospective, opened study to evaluate the impact of Health Literacy Levels on CPAP withdrawal in Obstructive Sleep Apnea patients within 6 months of inclusion.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 22, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

May 17, 2022

Last Update Submit

February 2, 2024

Conditions

Adherence, TreatmentHealth LiteracyObstructive Sleep Apnea

Keywords

Adherencetreatment refusalCPAPObstructive sleep apneaHealth literacy

Outcome Measures

Primary Outcomes (1)

  • To study the impact of health literacy levels on CPAP discontinuation in newly fitted OSA patients

    Proportion of CPAP treatment discontinuation without switch to mandibular advancement orthosis treatment

    Between initiation of CPAP (day 7 to 15 after inclusion) to V2 (6 months after inclusion)

Secondary Outcomes (11)

  • To study the impact of health literacy levels on CPAP refusal after diagnosis.

    At V1 (inclusion)

  • To investigate the impact of health literacy levels on adherence status. With adherence status defined here in several ways (≥4h vs <4h; adherence quartiles or adherence clusters).

    At 6 month (V2)

  • To study the interactions between the different socio-economic factors studied and their influence on adherence to the CPAP treatment

    At 6 month

  • Define the relationship between various clinical, social, economic, environmental determinants and adherence in addition to health literacy.

    At 6 months

  • Identify profiles of patients who refuse CPAP or are non- adherent or who have stopped CPAP according to personal determinants

    At 6 months

  • +6 more secondary outcomes

Eligibility Criteria

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

Obstructive Sleep Apnea patients with cPAP indication

You may qualify if:

  • Patient newly diagnosed with OSA
  • Patient with indication for CPAP
  • Voluntary patient with informed consent and no objection to participation
  • Patient affiliated with or benefiting from a social security plan
  • Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curators) according to articles L1121-5 to L1121-8
  • Refusal of participation by the patient
  • Patient refusing telemonitoring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHUGA

La Tronche, 38043, France

RECRUITING

Centre du Sommeil de Grenoble

Saint-Martin-d'Hères, France

RECRUITING

Related Publications (2)

  • Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.

    PMID: 31300334RESULT

  • Bailly S, Foote A, Mendelson M, Rakotovao A, Borel JC, Pepin JL, Tamisier R, Revil H. Sociological determinants of adherence to continuous positive airway pressure in the management of sleep apnoea syndrome: protocol for a transdisciplinary, prospective observational study. BMJ Open. 2024 Mar 5;14(3):e079765. doi: 10.1136/bmjopen-2023-079765.

    PMID: 38448064DERIVED

MeSH Terms

Conditions

Treatment Adherence and ComplianceSleep Apnea, ObstructiveTreatment Refusal

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Sébastien Bailly, PharmD, PhD

    Sleep and respiratory diseases Lab, CHU Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien Bailly, PharmD, PhD

CONTACT

+33 476 766 918sbailly@chu-grenoble.fr

Andry Rakotovao, PhD

CONTACT

+33 476 769 265arakotovao@chu-grenoble.fr

Study Design

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

Study Record Dates

First Submitted

May 17, 2022

First Posted

May 23, 2022

Study Start

September 22, 2022

Primary Completion

December 1, 2024

Study Completion

July 1, 2025

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)