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NCT04894175 Clinical Trial

Association Between Treatment Adherence and Treatment Adherence in Sleep Apnea (SEMSAS)

Obstructive Sleep Apnea Clinical Trial

— SEMSAS  

Official title:
Association Between Treatment Perception and Treatment Adherence in Obstructive Sleep Apnea Patients Treated by Continuous Positive Airway Pressure (SEMSAS Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04894175
Other study ID # 20.09.01.60526
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 25, 2021
Est. completion date December 31, 2022

Study information
Verified date January 2023
Source Auxilair
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 302
Est. completion date December 31, 2022
Est. primary completion date May 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Obstructive Sleep apnea diagnosed, whatever the initial severity and treated with CPAP - Voluntary patient - patient in the national healthcare insurance system Exclusion Criteria: - Patient with central sleep apnea - Treatment other than CPAP - Person with liberty privation or under legal protection

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Gentina Lille

Sponsors (1)
Lead Sponsor Collaborator
Thibaut Gentina

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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 To compute an overall score to predict CPAP adherence Use Self-efficacy Measure for Sleep Apnea (SEMSA-15) scale and socio-economics parameter from patients to improve CPAP adherence prediction 3-month and 1-year
Secondary To study the impact of health litteracy on CPAP adherence Use of Health Litteracy Questionnaire HLQ 3-month and 1-year
Secondary To study the impact of precariousness on CPAP adherence Use of Deprivation in Primary Care (DIPCARE-Q) questionnaire 3-month and 1-year
Secondary To study the impact of patient quality of life on CPAP adherence Use of simplified Short-Form (SF-36) questionnaire for quality of life (SF-12 questionnaire) 3-month and 1-year
Secondary To construct an overall predictive model of CPAP adherence CPAP Adherence 3-month and 1-year
Secondary To assess the interactions between CPAP adherence trajectories and patients parameters CPAP adherence trajectories 3-month and 1-year
Secondary to assess the improvement of quality of life according to health litteracy and precariousness Quality of life 1-year
Secondary Define patient phenotype according all collected variables Clinical and socio-demographic phenotype at CPAP initiation At inclusion
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