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Taking people in CroatiaNo phase

Boosting CPAP Use in Adults With Severe Sleep Apnea: Role of Motivation and Psychological Factors

Key facts

Who runs it
University of Split, School of Medicine
Where
Split, CroatiaSee the site
Trial code
Status
Recruiting
People taking part
100 people, planned
Started
14 Apr 2025
Planned end
1 Apr 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Motivational Telephone Call
Record updated
29 May 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Participants aged 18 years or older
  • Diagnosis of severe obstructive sleep apnea (OSA), defined as AHI ≥30
  • Signed informed consent for participation in the study
  • Adequate physical and psychological capacity to participate in the intervention and complete questionnaires
  • Patients who are initiating CPAP therapy at the Sleep Medicine Center, University of Split School of Medicine
  • Availability for follow-up over a three-month period

Who cannot take part

  • Previous experience with CPAP therapy prior to study enrollment
  • Presence of central sleep apnea or other primary sleep disorders
  • Cognitive impairment or psychiatric conditions that may hinder the ability to follow instructions or complete questionnaires
  • Significant comorbidities (e.g. unstable cardiovascular disease, advanced pulmonary disease) that may interfere with study outcomes
  • Pregnancy
  • Inability to participate in follow-up assessments or be contacted by telephone

Where in Croatia

  • University of Split School of MedicineSplit, CroatiaContact: Ivana Pavlinac Dodig, Assoc. Prof.Taking people

About the trial

What the trial wants to find out

The goal of this randomized prospective clinical trial is to examine whether phenotypic traits, psychological characteristics, assessed by STAI (engl. The State-Trait Anxiety Inventory) and IPIP50S (engl. International Personality Item Pool) questionnaires, and patients' self-efficacy, assessed by SEMSA (engl. Self-Eficacy Measure for Sleep Apnea) questionnaire, are associated with CPAP adherence after three months of use. The study also evaluates whether a motivational phone call one month after therapy initiation improves CPAP adherence at the three-month follow-up. The main questions it aims to answer are:

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* Are phenotypic and psychological traits associated with adherence to CPAP therapy after 3 months of treatment? * Can a single motivational telephone intervention, one month after initiating CPAP therapy, significantly improve CPAP adherence at the three-month follow-up compared to no intervention? Researchers will compare patients who receive a phone call to those who do not, to see if this simple intervention leads to better CPAP adherence after three months of use.

Participants will:

* Undergo polysomnography before starting CPAP therapy, * Complete three questionnaires (IPIP50S, STAI, SEMSA) before starting CPAP therapy, * Be randomly assigned to either receive a motivational phone call one month after starting CPAP therapy or to a control group without any phone call, * Be invited for a follow-up after three months of CPAP use to download and analyze CPAP adherence data from their CPAP devices.

The 2 groups in the trial

  • Motivational Telephone Call - Intervention GroupTreatment being tested

    Participants in this group will receive standard CPAP therapy along with a motivational telephone intervention. Approximately one month after initiating CPAP therapy, a physician will contact participants by phone to assess usage and discuss any difficulties. During the call, the physician will provide personalized motivation and education regarding the health benefits of consistent CPAP use to enhance treatment adherence. Timing: At 1 month post-enrollment Delivered by: Medical doctor Mode: Telephone Goal: To improve CPAP adherence at the 3-month follow-up

    Treatment: Motivational Telephone Call

  • No Intervention - Control GroupNo study treatment, for comparison

    Participants in this group will receive standard CPAP therapy only, without any additional motivational contact beyond routine clinical follow-up. Data on adherence will be collected at the 3-month time point using CPAP device memory cards.

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

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Impact of Phenotypic and Psychological Characteristics and a Motivational Telephone Intervention on Continuous Positive Airway Pressure (CPAP) Adherence in Patients With Severe Obstructive Sleep Apnea
Record updated
29 May 2025