Motivational program to improve sleep quality in patients with sleep apnea
Evaluation of the Effectiveness of a Brief Motivational Educational Program to Improve Sleep Quality in OSA Patients Through Adherence to CPAP
NA · Fondazione Don Carlo Gnocchi Onlus · NCT06668597
This study is testing a new motivational program to see if it can help adults with sleep apnea sleep better and stick to their CPAP therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus (other) |
| Locations | 2 sites (Milan, Milan and 1 other locations) |
| Trial ID | NCT06668597 on ClinicalTrials.gov |
What this trial studies
This study introduces a motivational intervention for adults with Obstructive Sleep Apnea (OSA) who are starting CPAP therapy. It aims to enhance sleep quality and treatment adherence by comparing an experimental group receiving a four-phase motivational program with a control group receiving standard care. The study will assess average daily CPAP use and evaluate subjective sleep quality, daytime sleepiness, disease perception, and quality of life. Participants must be able to understand Italian and are required to be adults beginning their CPAP adaptation process.
Who should consider this trial
Good fit: Ideal candidates are adult patients with mild to severe OSA who are beginning their CPAP adaptation and can understand Italian.
Not a fit: Patients who are minors, already adapted to CPAP, or unable to understand Italian may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve adherence to CPAP therapy and overall sleep quality for patients with OSA.
How similar studies have performed: Other studies have shown success with motivational interventions in improving adherence to treatment in various health conditions, suggesting potential for this approach in OSA management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Adult patients with OSA (divided, according to the Task Force of the American Academy of Sleep Medicine (Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The report of an American Academy of Sleep Medicine Task Force. Sleep. 1999;22(5):667-689) into: Mild OSA with AHI between 5 and 15 Moderate OSA with AHI between 15 and 30 Severe OSA with AHI \> 30 * OSA patients who need to begin their home adaptation process to CPAP * OSA patients who are able to understand the Italian language Exclusion Criteria: * Minor patients * Patients already adapted to CPAP * Patients unable to understand the Italian language
Where this trial is running
Milan, Milan and 1 other locations
- Don Gnocchi Foundation — Milan, Milan, Italy (RECRUITING)
- IRCCS Fondazione Don Gnocchi — Milan, MI, Italy (RECRUITING)
Study contacts
- Principal investigator: Eleonora Volpato, PhD — IRCCS Fondazione Don Gnocchi
- Study coordinator: Eleonora Volpato, PhD
- Email: eleonora.volpato@unicatt.it
- Phone: 3293782692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Motivational Intervention, Sleep Management, Telemedicine, Psychoeducation