Ireland
--:--IST
Recruiting Not applicable

Educational Motivational Program on Sleep Apnea

NCT06668597 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-01-08
Last updated
2025-02-10

Condition(s) studied

Obstructive Sleep Apnea (OSA)

Investigational drug(s) / intervention(s)

Motivational educational program to improve sleep quality in OSA patients through adherence to CPAP

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

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)

FacilityCityRegionStatus
Don Gnocchi Foundation Milan Milan Recruiting
IRCCS Fondazione Don Gnocchi Milan MI Recruiting
Official registry record

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