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

NCT ID: NCT06994247

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-14
• Study Completion Date: 2026-04-01

Brief 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.

Conditions

Obstructive Sleep Apnea (OSA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Motivational Telephone Call

Intervention Type: BEHAVIORAL

This intervention consists of a single, personalized motivational telephone call delivered by a medical doctor, one month after initiation of CPAP treatment, uniquely timed to address early barriers and enhance self-efficacy. Unlike standard care or automated follow-ups, it offers tailored support based on patient experience, making it a low-cost yet targeted behavioral strategy to improve adherence. Content of the telephone call includes inquiry about patient's experience with CPAP therapy, identification of barriers to regular use, education on the health benefits of consistent CPAP usage, and personalized motivational messages aimed at increasing compliance.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motivational Telephone Call

This intervention consists of a single, personalized motivational telephone call delivered by a medical doctor, one month after initiation of CPAP treatment, uniquely timed to address early barriers and enhance self-efficacy. Unlike standard care or automated follow-ups, it offers tailored support based on patient experience, making it a low-cost yet targeted behavioral strategy to improve adherence. Content of the telephone call includes inquiry about patient's experience with CPAP therapy, identification of barriers to regular use, education on the health benefits of consistent CPAP usage, and personalized motivational messages aimed at increasing compliance.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Previous experience with CPAP therapy prior to study enrollment
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Split, School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Split School of Medicine

Split, Dalmatia, Croatia

Site Status: RECRUITING

Countries

Croatia

Central Contacts

Ivana Pavlinac Dodig, Assoc. Prof.

Role: CONTACT

ivana.pavlinac@mefst.hr

+38521557853

Other Identifiers

2181-198-03-04-24-0107

Identifier Type: -

Identifier Source: org_study_id