Overview
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
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