Clinical Trial

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

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Record status
This record was last updated May 29, 2025 (before its estimated December 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
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: * 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.
Trial Details
NCT Number NCT06994247
Lead Sponsor University of Split, School of Medicine
Conditions Obstructive Sleep Apnea (OSA)
Enrollment 100 participants
Start Date 2025-04-14
Primary Completion 2025-12-15 (estimated)
Study Completion 2026-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-29