Evaluation of Self-efficacy as a Predictor for CPAP-compliance in a OSAS-patients French Cohort

NCT05053581 | Completed

• 1 other identifier: CHUBX 2020/45
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous positive airway pressure (CPAP) is the reference treatment for obstructive sleep apnea syndrome (OSAS) and is effective in improving symptoms of OSAS, reducing risk of accidents and improving quality of life. However, CPAP use is less than optimal. Recommended use is between 6-8 hour per night and a common clinical and empiric benchmark has been defined for CPAP use as an average of 4h per night for 70% of the night. Approximatively 30% of patients discontinue CPAP treatment during the first weeks. Thus, it is very important to identify the factors that influence CPAP adherence during the first weeks of treatment. Biomedical factors, in particular nose respiratory abnormalities, somnolence complaints and insomnia complaints, have been widely studied but explain only 4 to 25 % of the variance in CPAP use. Interestingly, "self-efficacy" (the confidence to engage in a treatment), was found to explain more than 30 % of the variance in CPAP use. The SEMSA (Self Efficacy in Sleep apnea) questionnaire is the instrument to investigate self-efficacy related to OSAS and CPAP that has received the most attention. Retrospective studies showed that the factor "self-efficacy" of the SEMSA was related to poor CPAP adherence. Prospective studies showed that the factor "self-efficacy" of the SEMSA at baseline was associated with future CPAP use when it was completed after education information. A French version of the SEMSA has been validated by investigators in a retrospective study. They have confirmed in France that the factor "self-efficacy" of the SEMSA was related to poor CPAP adherence. No prospective study using the SEMSA has been conducted in French patients with OSAS treated with CPAP. Given the specificity of the French health care system and home care system, it is thus important to evaluate the predictive value of self-efficacy on CPAP adherence in France. The generation of predictive model would enable pretreatment prediction of those likely to have difficulty with CPAP adherence, and would serve as the basis for the development of maximally effective interventions in order to enhance CPAP adherence by patients with OSAS.

Conditions

Sleep Apnea, Obstructive

Keywords

Continuous positive airway pressure therapy; Sleep Apnea; Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• CPAP Compliance M1

  Mean of the number of daily hours using CPAP on 30 days of data collection by telemonitoring before administration of M1 follow-up questionnaire

  Month 1 after CPAP initiation (inclusion)

Secondary Outcomes (11)

• CPAP Compliance M3 and M6

  Month 3 and Month 6 after CPAP initiation (inclusion)

• OSAS consequences et risk perception

  CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation

• Expected benefits of CPAP

  CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation

• Demographics before treatment

  CPAP initiation (inclusion)

• Insomnia Severity Index (ISI)

  CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation

Study Arms (1)

Patient

Other: Survey

Interventions

Survey OTHER

Patients will complete 7 questionnaires at inclusion (T0) and 1,3 and 6 months after start of CPAP treatment

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with new OSAS-diagnosed with CPAP as intended treatment

You may qualify if:

• Patients with new OSAS-diagnosed (Apnea-Hypopnea Index≥ 15) with CPAP as intended treatment
• Patients agreeing follow-up by telemonitoring
• Age between 18 and 65 years
• Affiliated person or beneficiary of a social security scheme
• Informed and expressed his/her non-opposition to engage in the study

You may not qualify if:

• Night-workers or shift-workers
• Current psychiatric disorder (mood disorders, anxiety disorders, psychosis, dependence interfering with nocturnal sleep) assessed by the investigator during medical interview
• Current neurologic disorders interfering with sleep (for example: neurodegeneratives diseases, stroke, epilepsy) assessed by the investigator during medical interview
• Uncontrolled cardiovascular or respiratory disorders
• Pregnant women or breastfeeding mother.
• Person under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Air Liquide Santé International: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

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

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 22, 2021
• Study Start: May 18, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)