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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Croatia
University of Split School of Medicine
RECRUITING
Split
Contact Information
Primary
Ivana Pavlinac Dodig, Assoc. Prof.
ivana.pavlinac@mefst.hr
+38521557853
Time Frame
Start Date: 2025-04-14
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 100
Treatments
Experimental: Motivational Telephone Call - Intervention Group
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
No_intervention: No Intervention - Control Group
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.
Related Therapeutic Areas
Sponsors
Leads: University of Split, School of Medicine

This content was sourced from clinicaltrials.gov