Obstructive Sleep Apnea SyndromeNCT04538274
Trained Patient Involvement to Promote the Resumption of CPAP in Patients Who Have Discontinued Its Use
A study testing peer-driven intervention in people with Obstructive Sleep Apnea Syndrome, run by AGIR à Dom.
Trial summary
The primary objective of this randomized clinical trial is to evaluate the role of patient researchers in promoting the resumption of CPAP therapy in apneic patients who had previously stopped CPAP Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- peer-driven intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- No sites listed yet
- Study dates
- 18 Feb 2025to 18 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Diagnosed with of severe OSA (AHI ≥ 30 events/hour)
- Discontinuation of CPAP 4 to 12 months after initiation Followed by the home health care provider Agiradom
- Access to a computer and/or tablet and an internet connection
- Oral and written French
- Able to provide written informed consent
- Affiliated to social security or beneficiary of such a scheme
Who cannot join
- CPAP cessation due to a resolution of the OSAS (e.g. weight loss after bariatric surgery) or another pathology that prevents the continuation of treatment (e.g. ENT surgery, etc.).
- Severe and/or unstable comorbidity that required hospitalisation for decompensation in the previous year (heart, kidney, respiratory, liver, psychiatric or other insufficiency).
- Patient being treated with a mandibular advancement orthosis
- Lack of availability (e.g. night worker or patient who travels frequently, etc.).
- Current participation in, participation in the month prior to inclusion in another clinical intervention research study that may impact the study: this impact is left to the investigator's discretion.
- Referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Raymon Merle contact
About this study
Official title: A Peer-driven Intervention to Help Patients Resume CPAP Therapy Following Discontinuation: a Multicenter, Randomized Clinical Trial with Patient Involvement
The primary objective of this randomized clinical trial is to evaluate the role of patient researchers in promoting the resumption of CPAP therapy in apneic patients who had previously stopped CPAP
Read the detailed description
Obstructive Sleep Apnoea syndrome (OSA) is one of the most frequent chronic disease presenting with or without symptoms of excessive daytime sleepiness (EDS) and being accompanied by neurocognitive, cardiovascular and metabolic complications.
The first line therapy of obstructive sleep apnoea is continuous positive airway pressure (CPAP). CPAP is highly effective in symptomatic patients for reducing EDS and improving daily functioning, cognitive function, mood and quality of life. However, success of CPAP treatment is hampered by long term nonadherence in nearly half of patients. Non adherence to CPAP is less and less related to technical problems, but rather to users' profile, their representations of OSA and the benefits experienced from CPAP. Cognitive-behavioural and motivation enhancement therapies can promote adherence to CPAP treatment. In addition to health professionals, patients and public involvement (PPI) is more and more advocated in the field of education and research. Nevertheless, the level of evidence regarding efficacy of PPI and patient researchers remains to be demonstrated. The aim of this randomized clinical trial is to evaluate the role of patient researchers in promoting the resumption of CPAP therapy in apneic patients who had previously stopped CPAP
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- peer-driven intervention
- Keywords
- Sleep Apnea, CPAP adherence, Patient and Public Involvement (PPI), cognitive-behavioural and motivation enhancement therapies, Patient Involvement (PI)
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peer-driven interventionBehavioural
Trained patient researchers will conduct 3 motivational sessions, according to the principle of motivational enhancement and cognitive-behavioral therapies, by videoconference meetings of 45 to 60 minutes duration with 5 to 8 patients within 6 months after each patient's inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Patient researcher intervention | Experimental | Intervention conducted by trained patient researchers to restart CPAP in addition to usual care Receives: Behavioral: peer-driven intervention |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation
The range of patients reusing CPAP in the intervention group The difference in percentages of patients who reuse CPAP between the peer-driven intervention group and the control group.
Measured: 6 months after inclusion
Secondary outcomes (21)
Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group
the difference in CPAP compliance (average hours of use/night) between the AP intervention group and a control group
Measured: 6 month after inclusion
Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group
the difference in percentages of patients who reuse to CPAP with at least 4 hours' use /night for 70% of nights
Measured: 6 month after inclusion
Disease-specific quality of life
The Functional Outcomes of Sleep Questionnaire (FOSQ10) will be completed at inclusion (M0) and at the 6-month follow-up (M6).
This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: At inclusion and after 6 months
Patient Self-Efficacy Measure for Sleep Apnea
The Self-Efficacy Measure for Sleep Apnea (SEMSA) questionnaire, a tool with strong psychometric properties and with the potential for identifying patient perceptions will be completed at inclusion (M0) and at the 6-month follow-up (M6). This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: At inclusion and after 6 months
Patient knowledge, skill, and confidence for self-management
The Patient Activation Measure (PAM) qestionnaire, a measure that assesses patient knowledge, skill, and confidence for self-management, will be completed at inclusion (M0) and at the 6-month follow-up (M6) This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: At inclusion and after 6 months
Patient satisfaction and peer satisfaction
Patient satisfaction with the peer-driven intervention at 6 months will be measured on a 4-point Likert scale : very dissatisfied, dissatisfied, satisfied, very satisfied.
Satisfaction of PI representatives will be measured on a 4-point Likert scale: very dissatisfied, dissatisfied, satisfied, very satisfied.
Measured: At 6 month after inclusion
Feasibility and the execution of the peer-driven intervention
Evaluate the feasibility and the execution of the peer-driven intervention
Measured: At 6 month after inclusion
Age
This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
Gender
This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
BMI Body Mass Index
This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
marital status with infants (<10 years) or not
This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
Education level
This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
employment and socio-professional status
This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
alcohol-smoking status
This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
fragility and social precariousness
EPICES score will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
medication adherence
Girerd Score. This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
OSA history
date of diagnosis of OSA
Measured: inclusion
CPAP treatment
Date of initiation of CPAP and date and cause of CPAP discontinuation
Measured: inclusion
Baseline Apnea-Hypopnea Index (AHI)
This variable will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
Excessive daytime sleepiness (EDS score)
Epworth Sleepiness Scale will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
Comorbidities
Charlson index will be used to assess predictors of positive response to patient researcher intervention
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start18 Feb 2025 (estimated)
- Primary completion18 Feb 2025
- Study completion18 Feb 2025 (estimated)
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 Apnea SyndromeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, multicentre, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538274
- Sponsor's protocol ID
- 2020-06
- Status last verified
- Feb 2025
- First submitted
- 14 Aug 2020
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merle R, Pison C, Logerot S, Deschaux C, Arnol N, Roustit M, Tamisier R, Pepin JL, Borel JC. Peer-driven intervention to help patients resume CPAP therapy following discontinuation: a multicentre, randomised clinical trial with patient involvement. BMJ Open. 2021 Oct 14;11(10):e053996. doi: 10.1136/bmjopen-2021-053996.
PubMed 34649850
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Peer-driven Intervention to Help Patients Resume CPAP Therapy Following Discontinuation: a Multicenter, Randomized Clinical Trial with Patient Involvement
- ClinicalTrials.gov ID
- NCT04538274
- Acronym / sponsor ID
- 2020-06
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Sleep Apnea, CPAP adherence, Patient and Public Involvement (PPI), cognitive-behavioural and motivation enhancement therapies, Patient Involvement (PI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Study start
- 18 Feb 2025 (estimated)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (estimated)
- First posted
- 4 Sep 2020 (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 primary objective of this randomized clinical trial is to evaluate the role of patient researchers in promoting the resumption of CPAP therapy in apneic patients who had previously stopped CPAP
Detailed description
Obstructive Sleep Apnoea syndrome (OSA) is one of the most frequent chronic disease presenting with or without symptoms of excessive daytime sleepiness (EDS) and being accompanied by neurocognitive, cardiovascular and metabolic complications.
The first line therapy of obstructive sleep apnoea is continuous positive airway pressure (CPAP). CPAP is highly effective in symptomatic patients for reducing EDS and improving daily functioning, cognitive function, mood and quality of life. However, success of CPAP treatment is hampered by long term nonadherence in nearly half of patients. Non adherence to CPAP is less and less related to technical problems, but rather to users' profile, their representations of OSA and the benefits experienced from CPAP. Cognitive-behavioural and motivation enhancement therapies can promote adherence to CPAP treatment. In addition to health professionals, patients and public involvement (PPI) is more and more advocated in the field of education and research. Nevertheless, the level of evidence regarding efficacy of PPI and patient researchers remains to be demonstrated. The aim of this randomized clinical trial is to evaluate the role of patient researchers in promoting the resumption of CPAP therapy in apneic patients who had previously stopped CPAP
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, multicentre, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Patient researcher intervention | Experimental | Behavioral: peer-driven interventionIntervention conducted by trained patient researchers to restart CPAP in addition to usual care |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 years old
- Diagnosed with of severe OSA (AHI ≥ 30 events/hour)
- Discontinuation of CPAP 4 to 12 months after initiation Followed by the home health care provider Agiradom
- Access to a computer and/or tablet and an internet connection
- Oral and written French
Key exclusion criteria (6 listed)
- CPAP cessation due to a resolution of the OSAS (e.g. weight loss after bariatric surgery) or another pathology that prevents the continuation of treatment (e.g. ENT surgery, etc.).
- Severe and/or unstable comorbidity that required hospitalisation for decompensation in the previous year (heart, kidney, respiratory, liver, psychiatric or other insufficiency).
- Patient being treated with a mandibular advancement orthosis
- Lack of availability (e.g. night worker or patient who travels frequently, etc.).
- Current participation in, participation in the month prior to inclusion in another clinical intervention research study that may impact the study: this impact is left to the investigator's discretion.
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 |
|---|---|---|
| peer-driven interventionTrained patient researchers will conduct 3 motivational sessions, according to the principle of motivational enhancement and cognitive-behavioral therapies, by videoconference meetings of 45 to 60 minutes duration with 5 to 8 patients within 6 months after each patient's inclusion. | Behavioural | Patient researcher intervention |
Primary outcome
Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation
Time frame: 6 months after inclusion
The range of patients reusing CPAP in the intervention group The difference in percentages of patients who reuse CPAP between the peer-driven intervention group and the control group.
21 secondary outcomes
Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group
Time frame: 6 month after inclusion
Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group
Time frame: 6 month after inclusion
Disease-specific quality of life
Time frame: At inclusion and after 6 months
Patient Self-Efficacy Measure for Sleep Apnea
Time frame: At inclusion and after 6 months
Patient knowledge, skill, and confidence for self-management
Time frame: At inclusion and after 6 months
Patient satisfaction and peer satisfaction
Time frame: At 6 month after inclusion
Feasibility and the execution of the peer-driven intervention
Time frame: At 6 month after inclusion
Age
Time frame: inclusion
Gender
Time frame: inclusion
BMI Body Mass Index
Time frame: inclusion
marital status with infants (<10 years) or not
Time frame: inclusion
Education level
Time frame: inclusion
employment and socio-professional status
Time frame: inclusion
alcohol-smoking status
Time frame: inclusion
fragility and social precariousness
Time frame: inclusion
medication adherence
Time frame: inclusion
OSA history
Time frame: inclusion
CPAP treatment
Time frame: inclusion
Baseline Apnea-Hypopnea Index (AHI)
Time frame: inclusion
Excessive daytime sleepiness (EDS score)
Time frame: inclusion
Comorbidities
Time frame: inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Derived from this study: PubMed 34649850Merle R, Pison C, Logerot S, Deschaux C, Arnol N, Roustit M, Tamisier R, Pepin JL, Borel JC. Peer-driven intervention to help patients resume CPAP therapy following discontinuation: a multicentre, randomised clinical trial with patient involvement. BMJ Open. 2021 Oct 14;11(10):e053996. doi: 10.1136/bmjopen-2021-053996.
- 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.
Raymon Merle contact
Questions about this trial
What is this clinical trial studying?
A study testing peer-driven intervention in people with Obstructive Sleep Apnea Syndrome, run by AGIR à Dom.
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 7 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: opening soon, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Pison, MD (04 76 76 54 53 ext. +33, CPison@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation (time frame: 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 NCT04538274, 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 20 Feb 2025.