NCT06994247 Boosting CPAP Use in Adults With Severe Sleep Apnea: Role of Motivation and Psychological Factors
| NCT ID | NCT06994247 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Split, School of Medicine |
| Condition | Obstructive Sleep Apnea (OSA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-14 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-04-14 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06994247 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea (OSA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06994247 currently recruiting?
Yes, NCT06994247 is actively recruiting participants. Contact the research team at ivana.pavlinac@mefst.hr for enrollment information.
Where is the NCT06994247 trial being conducted?
This trial is being conducted at Split, Croatia.
Who is sponsoring the NCT06994247 clinical trial?
NCT06994247 is sponsored by University of Split, School of Medicine. The trial plans to enroll 100 participants.