Clinical trial NCT04538274: Trained Patient Involvement to Promote the Resumption of CPAP in Patients Who Have Discontinued Its Use
Official title: A Peer-driven Intervention to Help Patients Resume CPAP Therapy Following Discontinuation: a Multicenter, Randomized Clinical Trial with Patient Involvement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Sleep Apnea
CPAP adherence
Patient and Public Involvement (PPI)
cognitive-behavioural and motivation enhancement therapies
Patient Involvement (PI)
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, multicentre, randomized controlled trial
Primary purpose: OTHER

Brief 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

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group
timeFrame: 6 month after inclusion
measure: Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group
timeFrame: 6 month after inclusion
measure: Disease-specific quality of life
timeFrame: At inclusion and after 6 months
measure: Patient Self-Efficacy Measure for Sleep Apnea
timeFrame: At inclusion and after 6 months
measure: Patient knowledge, skill, and confidence for self-management
timeFrame: At inclusion and after 6 months
measure: Patient satisfaction and peer satisfaction
timeFrame: At 6 month after inclusion
measure: Feasibility and the execution of the peer-driven intervention
timeFrame: At 6 month after inclusion
measure: Age
timeFrame: inclusion
measure: Gender
timeFrame: inclusion
measure: BMI Body Mass Index
timeFrame: inclusion
measure: marital status with infants (<10 years) or not
timeFrame: inclusion
measure: Education level
timeFrame: inclusion
measure: employment and socio-professional status
timeFrame: inclusion
measure: alcohol-smoking status
timeFrame: inclusion
measure: fragility and social precariousness
timeFrame: inclusion
measure: medication adherence
timeFrame: inclusion
measure: OSA history
timeFrame: inclusion
measure: CPAP treatment
timeFrame: inclusion
measure: Baseline Apnea-Hypopnea Index (AHI)
timeFrame: inclusion
measure: Excessive daytime sleepiness (EDS score)
timeFrame: inclusion
measure: Comorbidities
timeFrame: inclusion
Other outcomes:
Locations:
Study officials:
References:
citation: 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.