Sign in
Taking peopleNo phase

Motivational program to help people with sleep apnea use their CPAP

Tests a motivational program for adults with obstructive sleep apnea starting CPAP.

Key facts

Who runs it
Fondazione Don Carlo Gnocchi ETS
Where
Italy2 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Educational Motivational Program on Sleep Apnea
Status
Recruiting
People taking part
60 people, planned
Started
8 Jan 2025
Planned end
Apr 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Motivational educational program to improve sleep quality in OSA patients through adherence to CPAP
Record updated
10 February 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with obstructive sleep apnea (OSA, breathing stops during sleep) who are about to start CPAP at home. CPAP is a machine that blows air through a mask.

Age
18 Years and older
Sex
All sexes
Disease stage
Mild OSA (AHI between 5 and 15), moderate OSA (AHI between 15 and 30) or severe OSA (AHI > 30). AHI counts breathing pauses per hour of sleep.
Earlier treatment
People must need to begin getting used to CPAP at home. People already used to CPAP cannot join.

Main reasons for not taking part

  • Under 18 years old
  • Already used to CPAP
  • Unable to understand the Italian language

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Minor patients
  • Patients already adapted to CPAP
  • Patients unable to understand the Italian language

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Psychoeducation ProgramTreatment being tested

    The experimental group will receive a motivational psychoeducational intervention consisting of four phases: Phase 1 (Pre-adaptation Psychoeducation): The intervention begins with the pulmonologist's decision for home adaptation to CPAP for the patient diagnosed with OSA. The participant will receive necessary materials and an educational video (25 minutes) within two days before the provider's home visit. Phase 2 (Motivational Interview): After the first night of CPAP use, the participant will have a brief motivational interview via phone. Phase 3 (Psychological Support Interview): One week after the provider's intervention, the participant will have a support interview regarding the adaptation process (40 minutes). This first week is a high-risk period for device abandonment. Phase 4 (Monitoring Interview): Two weeks after the provider's intervention, the participant will have a monitoring interview (30 minutes) to check for any difficulties during the adaptation process.

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

  • Treatment as usualNo study treatment, for comparison

    The patient, following the visit with the pulmonologist specializing in sleep medicine, who has been diagnosed with OSA, will be invited to proceed with the home adaptation process for the CPAP device by the staff.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of the Effectiveness of a Brief Motivational Educational Program to Improve Sleep Quality in OSA Patients Through Adherence to CPAP
Plain-language title
Motivational program to help people with sleep apnea use their CPAPGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
10 February 2025