Actively Recruiting
Impact of Phenotypic and Psychological Characteristics and a Motivational Telephone Intervention on CPAP Adherence in Adults With Severe Obstructive Sleep Apnea
Led by University of Split, School of Medicine · Updated on 2025-05-29
100
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether certain physical and psychological traits, as well as a motivational phone call, affect how well adults with severe obstructive sleep apnea (OSA) stick to their CPAP therapy over three months. The study focuses on traits assessed by anxiety and personality questionnaires and a self-efficacy questionnaire related to sleep apnea treatment. It also aims to find out if a single motivational phone call one month after starting CPAP helps improve adherence compared to usual care. Participants will first undergo a sleep study (polysomnography) and complete three questionnaires before beginning CPAP therapy. They will then be randomly assigned to one of two groups: one receiving a motivational phone call from a doctor one month after starting CPAP, and the other receiving standard CPAP therapy without this call. The phone call includes personalized support and education to encourage regular CPAP use. During the study, participants will be followed for three months. At the end of this period, researchers will collect data directly from the CPAP devices to measure adherence. They will also analyze the baseline psychological assessments and the effect of the motivational call on CPAP use. This approach helps to understand factors influencing treatment adherence and the potential benefit of motivational support.
CONDITIONS
Brief Title
Boosting CPAP Use in Adults With Severe Sleep Apnea: Role of Motivation and Psychological Factors
Who Can Participate
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants begin CPAP therapy to treat severe obstructive sleep apnea. One month after starting therapy, participants in the intervention group receive a personalized motivational telephone call from a physician to support adherence, while the control group continues with standard care.
Initial enrollment visit and 1 follow-up telephone call at 1 month for the intervention group
Duration - At 3 months from enrollment
Participants' adherence to CPAP therapy is assessed at the 3-month mark using device memory cards to evaluate treatment effectiveness.
1 visit (in-person) for adherence assessment
Trial Site Locations
Total: 1 location
1
University of Split School of Medicine
Split, Dalmatia, Croatia, 21000
Actively Recruiting
Research Team
I
Ivana Pavlinac Dodig, Assoc. Prof.
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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