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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04894175

Acronym

SEMSAS

Enrollment

302

Registered

2021-05-20

Start date

2021-05-25

Completion date

2022-12-31

Last updated

2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Continuous positive airway pressure adherence	3-month	To define an optimal threshold for the Self-efficacy Measure for Sleep Apnea (SEMSA-15) scale to predict 3-month CPAP adherence

Secondary

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

Countries

France

Outcome results