Sleep Apnea, ObstructiveSAFESNCT05053581
Evaluation of Self-efficacy as a Predictor for CPAP-compliance in a OSAS-patients French Cohort
An observational study of Sleep Apnea, Obstructive, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Survey
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 18 May 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with new OSAS-diagnosed with CPAP as intended treatment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Survey
- Keywords
- Continuous positive airway pressure therapy, Sleep Apnea, Obstructive Sleep Apnea Syndrome
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Patients will complete 7 questionnaires at inclusion (T0) and 1,3 and 6 months after start of CPAP treatment
| Study group | Role | What they receive |
|---|---|---|
| Patient | Not described Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 1 after CPAP initiation (inclusion)
Secondary outcomes (11)
CPAP Compliance M3 and M6
Mean of the number of daily hours using CPAP on 30 days of data collection by telemonitoring
Measured: Month 3 and Month 6 after CPAP initiation (inclusion)
OSAS consequences et risk perception
Factor "perception of the consequences and risks of OSAS" of SEMSA questionnaire
Measured: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Expected benefits of CPAP
Factor "perception of the expected benefits of CPAP" of SEMSA questionnaire.
Measured: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Demographics before treatment
Demographic factors before CPAP treatment: age, sex, socio-professional category, marital status, body mass index, cardiovascular disorders, metabolic disorders, antidepressant treatments
Measured: CPAP initiation (inclusion)
Insomnia Severity Index (ISI)
Insomnia complaints with ISI questionnaire
Measured: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Epworth Sleepiness Scale (ESS) score
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'.
Measured: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Hypersomnia Severity Index (HSI)
Sleepiness complaints with HSI questionnaire
Measured: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Nasal Respiratory complaints
Nasal Respiratory complaints measured by NOSE questionnaire
Measured: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Depression symptoms
Depression symptoms measured by PHQ-4 questionnaire
Measured: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Anxiety symptoms
Anxiety symptoms measured by PHQ-4 questionnaire
Measured: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Reasons for CPAP initiation
Factors which led up to CPAP initiation
Measured: CPAP initiation (inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start18 May 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Air Liquide Santé International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053581
- Sponsor's protocol ID
- CHUBX 2020/45
- Acronym
- SAFES
- Status last verified
- Jun 2025
- First submitted
- 31 Aug 2021
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Self-efficacy as a Predictor for CPAP-compliance in a OSAS-patients French Cohort
- ClinicalTrials.gov ID
- NCT05053581
- Acronym / sponsor ID
- SAFES / CHUBX 2020/45
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Continuous positive airway pressure therapy, Sleep Apnea, Obstructive Sleep Apnea Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Air Liquide Santé International
- Study start
- 18 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with new OSAS-diagnosed with CPAP as intended treatment
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyPatients will complete 7 questionnaires at inclusion (T0) and 1,3 and 6 months after start of CPAP treatment | Other | Patient |
Primary outcome
CPAP Compliance M1
Time frame: 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
11 secondary outcomes
CPAP Compliance M3 and M6
Time frame: Month 3 and Month 6 after CPAP initiation (inclusion)
OSAS consequences et risk perception
Time frame: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Expected benefits of CPAP
Time frame: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Demographics before treatment
Time frame: CPAP initiation (inclusion)
Insomnia Severity Index (ISI)
Time frame: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Epworth Sleepiness Scale (ESS) score
Time frame: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Hypersomnia Severity Index (HSI)
Time frame: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Nasal Respiratory complaints
Time frame: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Depression symptoms
Time frame: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Anxiety symptoms
Time frame: CPAP initiation (inclusion), then Month 1, Month 3, and Month 6 after CPAP initiation
Reasons for CPAP initiation
Time frame: CPAP initiation (inclusion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP Compliance M1 (time frame: Month 1 after CPAP initiation (inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.