Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06994247

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

Led by University of Split, School of Medicine · Updated on 2025-05-29

100

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 18 years or older
  • Diagnosis of severe obstructive sleep apnea (OSA), defined as AHI 630
  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Split School of Medicine

Split, Dalmatia, Croatia, 21000

Actively Recruiting

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Research Team

I

Ivana Pavlinac Dodig, Assoc. Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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