NCT04894175

Brief Summary

The objective of the study is to define an optimal threshold of the SEMSA-15 scale for obstructive sleep apnea (OSA) perception in patients with OSA to predict 3-month and 1-year continuous positive airway pressure adherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

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

First Submitted

Initial submission to the registry

May 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

May 25, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

May 12, 2021

Last Update Submit

January 30, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Continuous positive airway pressure adherence

    To define an optimal threshold for the Self-efficacy Measure for Sleep Apnea (SEMSA-15) scale to predict 3-month CPAP adherence

    3-month

  • Continuous positive airway pressure adherence

    To define an optimal threshold for the Self-efficacy Measure for Sleep Apnea (SEMSA-15) scale to predict 1-year CPAP adherence

    1-year

Secondary Outcomes (8)

  • To compute an overall score to predict CPAP adherence

    3-month and 1-year

  • To study the impact of health litteracy on CPAP adherence

    3-month and 1-year

  • To study the impact of precariousness on CPAP adherence

    3-month and 1-year

  • To study the impact of patient quality of life on CPAP adherence

    3-month and 1-year

  • To construct an overall predictive model of CPAP adherence

    3-month and 1-year

  • +3 more secondary outcomes

Eligibility Criteria

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

Population will be screened by clinicians (pulmonologists) in ambulatory medicine

You may qualify if:

  • Obstructive Sleep apnea diagnosed, whatever the initial severity and treated with CPAP
  • Voluntary patient
  • patient in the national healthcare insurance system

You may not qualify if:

  • Patient with central sleep apnea
  • Treatment other than CPAP
  • Person with liberty privation or under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentina

Lille, 59000, France

Location

Related Publications (1)

  • Gentina T, Micoulaud-Franchi JA, Gentina E, Wang KP, Pepin JL, Bailly S. Association between Self-Efficacy and 1-Year Continuous Positive Airway Pressure Adherence Trajectories: Insight from the SEMSAS Study. Ann Am Thorac Soc. 2025 Dec;22(12):1942-1950. doi: 10.1513/AnnalsATS.202502-231OC.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Thibaut Gentina, MD

    Hopital La Louvière

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 20, 2021

Study Start

May 25, 2021

Primary Completion

May 25, 2022

Study Completion

December 31, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations