About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.).
Trial design
Parallel
Treatments tested in this trial
peer-driven intervention
BehavioralTrained 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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
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
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
Locations
This trial is not recruiting at the moment. You can still explore other options: