Sleep Apnea, Obstructive
Conditions
Keywords
Continuous positive airway pressure therapy, Sleep Apnea, Obstructive Sleep Apnea Syndrome
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.
Detailed description
Using a prospective design, investigators aim to examine the following factors: pre-treatment demographic factors, sleep clinical factors (Somnolence complaints with ESS questionnaire and Insomnia complaints with ISI questionnaire), patients' perceptions of self-efficacy (SEMSA questionnaire), and nose respiratory complaints (NOSE questionnaire). The objective is to investigate if self-efficacy would be the best predictor of CPAP use during the first month of treatment and at 3 and 6 months after treatment beginning. Impact of demographic factors, sleep and nose complaints will be taken into account. The study intend to recruit at the sleep clinic 150 patients with newly diagnosed Obstructive Sleep Apnea Syndrome for whom CPAP treatment is indicated. During the consultation of CPAP treatment initiation, the investigator will present the study and give the informed notice. If the patient agrees to participate, the investigator will notify the non-opposition of the patient in the medical file and confirm eligibility criteria. The patient will then complete 4 questionnaires (ISI, ESS, SEMSA, NOSE). After initiation of CPAP treatment, the same questionnaires will be sent to the patient 1 month, 3 and 6 months after treatment beginning. A Clinical Research Associate will call the patient to ensure the completion of questionnaires or in case of missing or incomplete data. The result of this study will give the opportunity to have a predictive model that enable pretreatment prediction of those likely to have difficulty with CPAP use, and would serve as the basis for the development of maximally effective interventions in order to enhance CPAP adherence by patients with OSAS.
Interventions
OTHERSurvey
Patients will complete 7 questionnaires at inclusion (T0) and 1,3 and 6 months after start of CPAP treatment
Sponsors
Air Liquide Santé International
University Hospital, Bordeaux
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP Compliance M1 | Month 1 after CPAP initiation (inclusion) | Mean of the number of daily hours using CPAP on 30 days of data collection by telemonitoring before administration of M1 follow-up questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OSAS consequences et risk perception | CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation | Factor perception of the consequences and risks of OSAS of SEMSA questionnaire |
| Expected benefits of CPAP | CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation | Factor perception of the expected benefits of CPAP of SEMSA questionnaire. |
| Demographics before treatment | CPAP initiation (inclusion) | Demographic factors before CPAP treatment: age, sex, socio-professional category, marital status, body mass index, cardiovascular disorders, metabolic disorders, antidepressant treatments |
| Insomnia Severity Index (ISI) | CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation | Insomnia complaints with ISI questionnaire |
| Epworth Sleepiness Scale (ESS) score | CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation | Sleepiness complaints with ESS (Epworth Sleepiness Scale) questionnaire. The ESS score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life, or their 'daytime sleepiness'. |
| CPAP Compliance M3 and M6 | Month 3 and Month 6 after CPAP initiation (inclusion) | Mean of the number of daily hours using CPAP on 30 days of data collection by telemonitoring |
| Nasal Respiratory complaints | CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation | Nasal Respiratory complaints measured by NOSE questionnaire |
| Depression symptoms | CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation | Depression symptoms measured by PHQ-4 questionnaire |
| Anxiety symptoms | CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation | Anxiety symptoms measured by PHQ-4 questionnaire |
| Reasons for CPAP initiation | CPAP initiation (inclusion) | Factors which led up to CPAP initiation |
| Hypersomnia Severity Index (HSI) | CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation | Sleepiness complaints with HSI questionnaire |
Countries
France
Outcome results
None listed