Adherence, TreatmentSOCIO-SASNCT05385302
Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
An observational study of Adherence, Treatment and Health Literacy, run by University Hospital, Grenoble at 2 sites in France.
Trial summary
Multicentric, prospective, opened study to evaluate the impact of Health Literacy Levels on CPAP withdrawal in Obstructive Sleep Apnea patients within 6 months of inclusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence, Treatment, Health Literacy, Obstructive Sleep Apnea
- How many people
- 250 participants
- Where
- 2 sitesFrance
- Study dates
- 22 Sep 2022to Jul 2025
- 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: Obstructive Sleep Apnea patients with cPAP indication
Who may be able to join
- Patient newly diagnosed with OSA
- Patient with indication for CPAP
- Voluntary patient with informed consent and no objection to participation
- Patient affiliated with or benefiting from a social security plan
- Non-Inclusion Criteria:
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curators) according to articles L1121-5 to L1121-8
- Refusal of participation by the patient
- Patient refusing telemonitoring
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHUGA
La Tronche, 38043
BAILLY, +3347676698, sbailly@chu-grenoble.fr
JL PEPIN
- Recruiting
Centre du Sommeil de Grenoble
Saint-Martin-d'Hères
Antonin Baldovi, antonin.baldovi@centre-sante-sommeil.fr
About this study
Official title: Sociological Determinants of Adherence to Continuous Positive Airway Pressure In the Management of Sleep Apnea Syndrome - A Transdisciplinary Approach.
Multicentric, prospective, opened study to evaluate the impact of Health Literacy Levels on CPAP withdrawal in Obstructive Sleep Apnea patients within 6 months of inclusion.
Read the detailed description
Obstructive sleep apnea syndrome (OSA) is a chronic multi-organ pathology and heterogeneous in its presentation and phenotypes.
To date, continuous positive airway pressure (CPAP) is the first-line treatment for OSA. In France, 1.2 million patients are treated with CPAP but 15% of patients refused the device at the time of diagnosis and the rate of non-adherence reach 43% 3 years after CPAP initiation.
Both in terms of sleepiness and cardiovascular symptoms, clinical improvement is correlated with normalization of ventilation and therefore with the use of CPAP throughout the sleep period by the patients. Adherence to CPAP is nowadays achieved by the contribution of tele-observance, which provides prescribers, home health care providers and patients with daily feedback on the effectiveness and compliance of the therapy.
To date, studies targeting the predictive factors of CPAP compliance in OSA patients mainly include clinical data (age, sex, severity of OSAS, symptoms, etc.), or technical factors directly related to CPAP treatment (type of mask, residual apnea hypopnea index (AHI) under treatment, leakage, side effects, etc.).
The social, socioeconomic and psychological approaches are far less studied and frankly underestimated, although they are gradually gaining interest, representing the submerged part of the iceberg. Some studies have shown an association between poor socioeconomic status and poor compliance with CPAP, while others have focused on psychological factors. Finally, in the work of our team, we have recently looked at the impact of the marital on compliance and the perception of the associated benefit. However, each study targets a specific area, without taking into account the clinical and individual determinants. Therefore, there is a lack of knowledge about individual determinants of CPAP adherence.
Health literacy, defined as "the ability to access, understand, evaluate, and communicate information in ways that promote, maintain, and improve one's health in a variety of settings across the lifespan" is a possible important limitation for a patient to understand the need for PAP treatment and was never explored in view to explain CPAP adherence.
This project aims to exploit a unique transdisciplinary approach to characterize refusal, discontinuation, and nonadherence to CPAP in patients with diagnosed OSA newly managed on CPAP.
The main hypothesis of the study is that a patient with an insufficient level of health literacy (LS) (score from 0 to 8 defined from the European Health Literacy Survey questionnaire) has a greater probability of stopping treatment early or of being non-compliant than a patient with better performance in terms of health literacy.
- Keywords
- Adherence, treatment refusal, CPAP, Obstructive sleep apnea, Health literacy
- Medical subject headings
- Treatment Adherence and Compliance, Sleep Apnea, Obstructive, Treatment Refusal
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the impact of health literacy levels on CPAP discontinuation in newly fitted OSA patients
Proportion of CPAP treatment discontinuation without switch to mandibular advancement orthosis treatment
Measured: Between initiation of CPAP (day 7 to 15 after inclusion) to V2 (6 months after inclusion)
Secondary outcomes (11)
To study the impact of health literacy levels on CPAP refusal after diagnosis.
Proportion of CPAP refusals after diagnosis
Measured: At V1 (inclusion)
To investigate the impact of health literacy levels on adherence status. With adherence status defined here in several ways (≥4h vs <4h; adherence quartiles or adherence clusters).
Average CPAP adherence
Measured: At 6 month (V2)
To study the interactions between the different socio-economic factors studied and their influence on adherence to the CPAP treatment
Average CPAP adherence
Measured: At 6 month
Define the relationship between various clinical, social, economic, environmental determinants and adherence in addition to health literacy.
Average CPAP adherence
Measured: At 6 months
Identify profiles of patients who refuse CPAP or are non- adherent or who have stopped CPAP according to personal determinants
Adherent, non-adherent, or discontinued status. With adherence status defined here in several ways (≥ 4 hours per night for at least 70% of the nights ; adherence quartiles or adherence clusters).
Measured: At 6 months
Determine adherence trajectories as a function of health literacy and specifically study the specific determinants of adherence.
Daily CPAP adherence data obtained by telemonitoring
Measured: Over 6 months
To decipher the links made by people in treatment discontinuation or qualified as non-observant from the medical point of view, between the different factors of non-observance identified.
Criteria identified on the basis of analyses of the corpus carried out from semi-structured interviews concerning knowledge of the pathology, the relationship with the treatment, the relationship with health professionals, and the life trajectory in terms of health care, making it possible to better understand patients' non-adherence.
Measured: within 15 days of refusal of CPAP treatment, or within 15 days of discontinuation of treatment during the 6-month follow-up, or within 15 days of visit 2 for both non-adherent and adherent patients at 6 months.
Understand how people explain these situations based on their life contexts, representations of the disease and treatment, particularly their understanding of the issues involved.
Criteria identified on the basis of analyses of the corpus carried out from semi-structured interviews concerning knowledge of the pathology, the relationship with the treatment, the relationship with health professionals, and the life trajectory in terms of health care, making it possible to better understand patients' non-adherence.
Measured: Within 15 days of refusal of treatment for patients refusing CPAP, or within 15 days of discontinuation of treatment for patients who stopped treatment during the 6-month follow-up, or within 15 days of visit 2 for non-adherent patients at 6 month
Analyze people's perceptions of their health information practices, their relationship with the medical profession and the role of those involved in their pathology to understanding CPAP treatment
Criteria identified on the basis of analyses of the corpus carried out from semi-structured interviews concerning knowledge of the pathology, the relationship with the treatment, the relationship with health professionals, and the life trajectory in terms of health care, making it possible to better understand patients' non-adherence.
Measured: Within 15 days of refusal of treatment for patients refusing CPAP, or within 15 days of discontinuation of treatment during the 6-month follow-up, or within 15 days of visit 2 for all patients at 6 month
Identify the change in adherent patient's relationship to their treatment and the perceived benefits
Criteria identified on the basis of analyses of the corpus carried out from semi-structured interviews concerning knowledge of the pathology, the relationship with the treatment, the relationship with health professionals, and the life trajectory in terms of health care, making it possible to better understand patients' adherence.
Measured: Within 6 months of the first interview
Describe the evolution of non-adherent patient's situation, the health and potential compensation strategies or alternatives that they have implemented to limit the impact of their untreated OSAS
Criteria identified on the basis of analyses of the corpus carried out from semi-structured interviews concerning knowledge of the pathology, the relationship with the treatment, the relationship with health professionals, and the life trajectory in terms of health care, making it possible to better understand patients' non-adherence.
Measured: Within 6 months of the first interview for non-adherent patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start22 Sep 2022
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adherence, TreatmentStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- ODENORE, HP2 Laboratory
- Responsible party
- Sponsor
- Investigators
- Sébastien Bailly, PharmD, PhD, Principal investigator, Sleep and respiratory diseases Lab, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385302
- Sponsor's protocol ID
- 38RC21.0367
- Acronym
- SOCIO-SAS
- Status last verified
- Feb 2024
- First submitted
- 17 May 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.
PubMed 31300334Bailly S, Foote A, Mendelson M, Rakotovao A, Borel JC, Pepin JL, Tamisier R, Revil H. Sociological determinants of adherence to continuous positive airway pressure in the management of sleep apnoea syndrome: protocol for a transdisciplinary, prospective observational study. BMJ Open. 2024 Mar 5;14(3):e079765. doi: 10.1136/bmjopen-2023-079765.
PubMed 38448064
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sociological Determinants of Adherence to Continuous Positive Airway Pressure In the Management of Sleep Apnea Syndrome - A Transdisciplinary Approach.
- ClinicalTrials.gov ID
- NCT05385302
- Acronym / sponsor ID
- SOCIO-SAS / 38RC21.0367
- Keywords
- Adherence, treatment refusal, CPAP, Obstructive sleep apnea, Health literacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- ODENORE, HP2 Laboratory
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 23 May 2022 (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.
Multicentric, prospective, opened study to evaluate the impact of Health Literacy Levels on CPAP withdrawal in Obstructive Sleep Apnea patients within 6 months of inclusion.
Detailed description
Obstructive sleep apnea syndrome (OSA) is a chronic multi-organ pathology and heterogeneous in its presentation and phenotypes.
To date, continuous positive airway pressure (CPAP) is the first-line treatment for OSA. In France, 1.2 million patients are treated with CPAP but 15% of patients refused the device at the time of diagnosis and the rate of non-adherence reach 43% 3 years after CPAP initiation.
Both in terms of sleepiness and cardiovascular symptoms, clinical improvement is correlated with normalization of ventilation and therefore with the use of CPAP throughout the sleep period by the patients. Adherence to CPAP is nowadays achieved by the contribution of tele-observance, which provides prescribers, home health care providers and patients with daily feedback on the effectiveness and compliance of the therapy.
To date, studies targeting the predictive factors of CPAP compliance in OSA patients mainly include clinical data (age, sex, severity of OSAS, symptoms, etc.), or technical factors directly related to CPAP treatment (type of mask, residual apnea hypopnea index (AHI) under treatment, leakage, side effects, etc.).
The social, socioeconomic and psychological approaches are far less studied and frankly underestimated, although they are gradually gaining interest, representing the submerged part of the iceberg. Some studies have shown an association between poor socioeconomic status and poor compliance with CPAP, while others have focused on psychological factors. Finally, in the work of our team, we have recently looked at the impact of the marital on compliance and the perception of the associated benefit. However, each study targets a specific area, without taking into account the clinical and individual determinants. Therefore, there is a lack of knowledge about individual determinants of CPAP adherence.
Health literacy, defined as "the ability to access, understand, evaluate, and communicate information in ways that promote, maintain, and improve one's health in a variety of settings across the lifespan" is a possible important limitation for a patient to understand the need for PAP treatment and was never explored in view to explain CPAP adherence.
This project aims to exploit a unique transdisciplinary approach to characterize refusal, discontinuation, and nonadherence to CPAP in patients with diagnosed OSA newly managed on CPAP.
The main hypothesis of the study is that a patient with an insufficient level of health literacy (LS) (score from 0 to 8 defined from the European Health Literacy Survey questionnaire) has a greater probability of stopping treatment early or of being non-compliant than a patient with better performance in terms of health literacy.
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
- Obstructive Sleep Apnea patients with cPAP indication
Key inclusion criteria (8 listed)
- Patient newly diagnosed with OSA
- Patient with indication for CPAP
- Voluntary patient with informed consent and no objection to participation
- Patient affiliated with or benefiting from a social security plan
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curators) according to articles L1121-5 to L1121-8
Key exclusion criteria (0 listed)
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
To study the impact of health literacy levels on CPAP discontinuation in newly fitted OSA patients
Time frame: Between initiation of CPAP (day 7 to 15 after inclusion) to V2 (6 months after inclusion)
Proportion of CPAP treatment discontinuation without switch to mandibular advancement orthosis treatment
11 secondary outcomes
To study the impact of health literacy levels on CPAP refusal after diagnosis.
Time frame: At V1 (inclusion)
To investigate the impact of health literacy levels on adherence status. With adherence status defined here in several ways (≥4h vs <4h; adherence quartiles or adherence clusters).
Time frame: At 6 month (V2)
To study the interactions between the different socio-economic factors studied and their influence on adherence to the CPAP treatment
Time frame: At 6 month
Define the relationship between various clinical, social, economic, environmental determinants and adherence in addition to health literacy.
Time frame: At 6 months
Identify profiles of patients who refuse CPAP or are non- adherent or who have stopped CPAP according to personal determinants
Time frame: At 6 months
Determine adherence trajectories as a function of health literacy and specifically study the specific determinants of adherence.
Time frame: Over 6 months
To decipher the links made by people in treatment discontinuation or qualified as non-observant from the medical point of view, between the different factors of non-observance identified.
Time frame: within 15 days of refusal of CPAP treatment, or within 15 days of discontinuation of treatment during the 6-month follow-up, or within 15 days of visit 2 for both non-adherent and adherent patients at 6 months.
Understand how people explain these situations based on their life contexts, representations of the disease and treatment, particularly their understanding of the issues involved.
Time frame: Within 15 days of refusal of treatment for patients refusing CPAP, or within 15 days of discontinuation of treatment for patients who stopped treatment during the 6-month follow-up, or within 15 days of visit 2 for non-adherent patients at 6 month
Analyze people's perceptions of their health information practices, their relationship with the medical profession and the role of those involved in their pathology to understanding CPAP treatment
Time frame: Within 15 days of refusal of treatment for patients refusing CPAP, or within 15 days of discontinuation of treatment during the 6-month follow-up, or within 15 days of visit 2 for all patients at 6 month
Identify the change in adherent patient's relationship to their treatment and the perceived benefits
Time frame: Within 6 months of the first interview
Describe the evolution of non-adherent patient's situation, the health and potential compensation strategies or alternatives that they have implemented to limit the impact of their untreated OSAS
Time frame: Within 6 months of the first interview for non-adherent patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Results publication: PubMed 31300334Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.
- Derived from this study: PubMed 38448064Bailly S, Foote A, Mendelson M, Rakotovao A, Borel JC, Pepin JL, Tamisier R, Revil H. Sociological determinants of adherence to continuous positive airway pressure in the management of sleep apnoea syndrome: protocol for a transdisciplinary, prospective observational study. BMJ Open. 2024 Mar 5;14(3):e079765. doi: 10.1136/bmjopen-2023-079765.
- 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.
Sébastien Bailly, PharmD, PhD principal investigator
Sleep and respiratory diseases Lab, CHU Grenoble Alpes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adherence, Treatment and Health Literacy, run by University Hospital, Grenoble at 2 sites 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 8 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien Bailly, PharmD, PhD (+33 476 766 918, sbailly@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the impact of health literacy levels on CPAP discontinuation in newly fitted OSA patients (time frame: Between initiation of CPAP (day 7 to 15 after inclusion) to V2 (6 months after inclusion)). 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 NCT05385302, which also lists 2 linked publications.
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 6 Feb 2024.