Obstructive Sleep ApneaSEMSASNCT04894175
Association Between Treatment Adherence and Treatment Adherence in Sleep Apnea (SEMSAS)
An observational study of Obstructive Sleep Apnea, run by Thibaut Gentina at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 302 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2021to 31 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Population will be screened by clinicians (pulmonologists) in ambulatory medicine
Who may be able to join
- Obstructive Sleep apnea diagnosed, whatever the initial severity and treated with CPAP
- Voluntary patient
- patient in the national healthcare insurance system
Who cannot join
- Patient with central sleep apnea
- Treatment other than CPAP
- Person with liberty privation or under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Treatment Perception and Treatment Adherence in Obstructive Sleep Apnea Patients Treated by Continuous Positive Airway Pressure (SEMSAS Study)
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.
- Conditions
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous positive airway pressure adherence
To define an optimal threshold for the Self-efficacy Measure for Sleep Apnea (SEMSA-15) scale to predict 3-month CPAP adherence
Measured: 3-month
Continuous positive airway pressure adherence
To define an optimal threshold for the Self-efficacy Measure for Sleep Apnea (SEMSA-15) scale to predict 1-year CPAP adherence
Measured: 1-year
Secondary outcomes (8)
To compute an overall score to predict CPAP adherence
Use Self-efficacy Measure for Sleep Apnea (SEMSA-15) scale and socio-economics parameter from patients to improve CPAP adherence prediction
Measured: 3-month and 1-year
To study the impact of health litteracy on CPAP adherence
Use of Health Litteracy Questionnaire HLQ
Measured: 3-month and 1-year
To study the impact of precariousness on CPAP adherence
Use of Deprivation in Primary Care (DIPCARE-Q) questionnaire
Measured: 3-month and 1-year
To study the impact of patient quality of life on CPAP adherence
Use of simplified Short-Form (SF-36) questionnaire for quality of life (SF-12 questionnaire)
Measured: 3-month and 1-year
To construct an overall predictive model of CPAP adherence
CPAP Adherence
Measured: 3-month and 1-year
To assess the interactions between CPAP adherence trajectories and patients parameters
CPAP adherence trajectories
Measured: 3-month and 1-year
to assess the improvement of quality of life according to health litteracy and precariousness
Quality of life
Measured: 1-year
Define patient phenotype according all collected variables
Clinical and socio-demographic phenotype at CPAP initiation
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start25 May 2021
- Primary completion25 May 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thibaut Gentina
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Thibaut Gentina, Auxilair
- Investigators
- Thibaut Gentina, MD, Principal investigator, Hopital La Louvière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894175
- Sponsor's protocol ID
- 20.09.01.60526
- Acronym
- SEMSAS
- Status last verified
- Jan 2023
- First submitted
- 12 May 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gentina T, Micoulaud-Franchi JA, Gentina E, Wang KP, Pepin JL, Bailly S. Association between Self-Efficacy and 1-Year Continuous Positive Airway Pressure Adherence Trajectories: Insight from the SEMSAS Study. Ann Am Thorac Soc. 2025 Dec;22(12):1942-1950. doi: 10.1513/AnnalsATS.202502-231OC.
PubMed 40680220
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Treatment Perception and Treatment Adherence in Obstructive Sleep Apnea Patients Treated by Continuous Positive Airway Pressure (SEMSAS Study)
- ClinicalTrials.gov ID
- NCT04894175
- Acronym / sponsor ID
- SEMSAS / 20.09.01.60526
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Thibaut GentinaIndustry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 May 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will be screened by clinicians (pulmonologists) in ambulatory medicine
Key inclusion criteria (3 listed)
- Obstructive Sleep apnea diagnosed, whatever the initial severity and treated with CPAP
- Voluntary patient
- patient in the national healthcare insurance system
Key exclusion criteria (3 listed)
- Patient with central sleep apnea
- Treatment other than CPAP
- Person with liberty privation or under legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
8 secondary outcomes
To compute an overall score to predict CPAP adherence
Time frame: 3-month and 1-year
To study the impact of health litteracy on CPAP adherence
Time frame: 3-month and 1-year
To study the impact of precariousness on CPAP adherence
Time frame: 3-month and 1-year
To study the impact of patient quality of life on CPAP adherence
Time frame: 3-month and 1-year
To construct an overall predictive model of CPAP adherence
Time frame: 3-month and 1-year
To assess the interactions between CPAP adherence trajectories and patients parameters
Time frame: 3-month and 1-year
to assess the improvement of quality of life according to health litteracy and precariousness
Time frame: 1-year
Define patient phenotype according all collected variables
Time frame: At 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 31 Jan 2023.
- Derived from this study: PubMed 40680220Gentina T, Micoulaud-Franchi JA, Gentina E, Wang KP, Pepin JL, Bailly S. Association between Self-Efficacy and 1-Year Continuous Positive Airway Pressure Adherence Trajectories: Insight from the SEMSAS Study. Ann Am Thorac Soc. 2025 Dec;22(12):1942-1950. doi: 10.1513/AnnalsATS.202502-231OC.
- 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.
Thibaut Gentina, MD principal investigator
Hopital La Louvière
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 Obstructive Sleep Apnea, run by Thibaut Gentina 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 3 inclusion and 3 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 31 Jan 2023. 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?
Continuous positive airway pressure adherence (time frame: 3-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894175, which also lists 1 linked publication.
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 31 Jan 2023.