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

NCT06994247 | Recruiting DMC

• 1 other identifier: 2181-198-03-04-24-0107
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• CPAP Adherence After Three Months of Therapy

  CPAP adherence at three months, measured as the percentage of days with CPAP usage ≥4 hours per night, obtained from CPAP device memory cards.

  From baseline (enrollment) to 3-month follow-up

Secondary Outcomes (4)

• Baseline self-efficacy related to OSA treatment

  Baseline

• Baseline anxiety levels (state and trait)

  Baseline

• Baseline personality traits

  Baseline

• Effect of motivational telephone intervention

  From baseline to 3-month follow-up

Study Arms (2)

Motivational Telephone Call - Intervention Group

EXPERIMENTAL

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

Behavioral: Motivational Telephone Call

No Intervention - Control Group

NO INTERVENTION

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.

Interventions

Motivational Telephone Call 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.

Motivational Telephone Call - Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Split, School of Medicine: lead

Study Sites (1)

University of Split School of Medicine

Split, Dalmatia, 21000, Croatia

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Ivana Pavlinac Dodig, Assoc. Prof.

CONTACT

+38521557853; ivana.pavlinac@mefst.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 29, 2025
• Study Start: April 14, 2025
• Primary Completion: December 15, 2025
• Study Completion: April 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)