Educational Motivational Program on Sleep Apnea
Condition(s) studied
Investigational drug(s) / intervention(s)
Motivational educational program to improve sleep quality in OSA patients through adherence to CPAP: Phase 1 (Pre-adaptation Psychoeducation): The participant will be shown, within two days prior to the home visit by the provider, which usually takes place within three days of the visit with the pulmonologist, the necessary materials (device, masks, and tubing), along with an educational video on the topic of OSA (duration 25 minutes); Phase 2 (Motivational Interview): Following the first night of titration and use of the CPAP, the participant will be contacted by phone for a brief motivational interview (duration 25 minutes); Phase 3 (Psychological Support Interview): One week after the provider's intervention and the start of the CPAP adaptation period, the participant will be contacted again for a support interview regarding the adaptation process to CPAP (duration 40 minutes). The first week of adaptation is considered a high-risk period for abandonment of device use; Phase 4 (Monitoring Interview): Two weeks after the provider's intervention and the start o
Study summary
The study aims to introduce a motivational intervention for patients with Obstructive Sleep Apnea (OSA) starting CPAP therapy to improve sleep quality and treatment adherence. It will assess average daily CPAP use and compare subjective sleep quality, daytime sleepiness, disease perception, and quality of life between the intervention group and a control group receiving standard care. Inclusion criteria are adults with OSA capable of understanding Italian; exclusion criteria are minors and those already adapted to CPAP. The experimental group will receive a four-phase motivational intervention, while the control group will follow standard CPAP adaptation without additional support.
Eligibility
Primary outcome measure(s)
- Brief Illness Perception Questionnaire — At enrollment, one week after the end of the intervention and three months later.
A self-report questionnaire consisting of 9 items, rated on a 10-point Likert scale, used to assess illness perception, ranging from mild to high. All of the items except the causal question are rated using a 0-to-10 response scale. The total score is calculated by summing the scores of all eight items where items 3, 4, and 7 are inversed. The possible range of scores is 0-80. The higher the score, the greater the perceived threat of the illness. - Pittsburgh Sleep Quality Index (PSQI) — At enrollment, one week after the end of the intervention and three months later.
A self-report questionnaire consisting of 10 items, using a 4-point Likert scale (0-3), used for the subjective assessment of sleep quality over the past month, specifically evaluating dimensions related to sleep efficiency and latency, duration, medication use, the presence of factors disturbing sleep (e.g., pain, heat, etc.), and the impact on quality of life. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. - Epworth Sleepiness Scale (ESS) — At enrollment, one week after the end of the intervention and three months later.
A self-report questionnaire consisting of 8 items on a 4-point Likert scale (0-3), used to assess daytime sleepiness in various daily life contexts, such as being a passenger in a car, reading, or attending a theater performance. The Epworth sleepiness scale results range from 0 to 24. Results from 0 to 10 show average (normal) daytime sleepiness. A result under 10 may not be cause for concern or it could identify you have trouble sleeping (insomnia). A result from 11 to 24 indicates excessive (abnormal) daytime sleepiness.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Don Gnocchi Foundation | Milan | Milan | Recruiting |
| IRCCS Fondazione Don Gnocchi | Milan | MI | Recruiting |
More Fondazione Don Carlo Gnocchi ETS trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06668597 on ClinicalTrials.gov ↗ ← All trials in Italy