Trials / Not Yet Recruiting
Not Yet RecruitingNCT04538274
Trained Patient Involvement to Promote the Resumption of CPAP in Patients Who Have Discontinued Its Use
A Peer-driven Intervention to Help Patients Resume CPAP Therapy Following Discontinuation: a Multicenter, Randomized Clinical Trial with Patient Involvement
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 208 (estimated)
- Sponsor
- AGIR à Dom · Academic / Other
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | peer-driven intervention | 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. |
Timeline
- Start date
- 2025-02-18
- Primary completion
- 2025-02-18
- Completion
- 2025-02-18
- First posted
- 2020-09-04
- Last updated
- 2025-02-20
Source: ClinicalTrials.gov record NCT04538274. Inclusion in this directory is not an endorsement.