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Completed

NCT Number: NCT04894175

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gentina

Lille, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Continuous positive airway pressure adherence

    Time frame: 3-month

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

  2. Continuous positive airway pressure adherence

    Time frame: 1-year

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

Secondary outcomes

  1. To compute an overall score to predict CPAP adherence

    Time frame: 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

  2. To study the impact of health litteracy on CPAP adherence

    Time frame: 3-month and 1-year

    Use of Health Litteracy Questionnaire HLQ

  3. To study the impact of precariousness on CPAP adherence

    Time frame: 3-month and 1-year

    Use of Deprivation in Primary Care (DIPCARE-Q) questionnaire

  4. To study the impact of patient quality of life on CPAP adherence

    Time frame: 3-month and 1-year

    Use of simplified Short-Form (SF-36) questionnaire for quality of life (SF-12 questionnaire)

  5. To construct an overall predictive model of CPAP adherence

    Time frame: 3-month and 1-year

    CPAP Adherence

  6. To assess the interactions between CPAP adherence trajectories and patients parameters

    Time frame: 3-month and 1-year

    CPAP adherence trajectories

  7. to assess the improvement of quality of life according to health litteracy and precariousness

    Time frame: 1-year

    Quality of life

  8. Define patient phenotype according all collected variables

    Time frame: At inclusion

    Clinical and socio-demographic phenotype at CPAP initiation

Sponsors and collaborators

Lead sponsor

Thibaut Gentina

Industry

Registry information

Official study title

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

Acronym: SEMSAS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 20, 2021
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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