Obstructive Sleep Apnea (OSA)
Conditions
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.
Interventions
BEHAVIORALMotivational Telephone Call
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.
Sponsors
University of Split, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP Adherence After Three Months of Therapy | From baseline (enrollment) to 3-month follow-up | CPAP adherence at three months, measured as the percentage of days with CPAP usage ≥4 hours per night, obtained from CPAP device memory cards. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline self-efficacy related to OSA treatment | Baseline | Self-efficacy related to obstructive sleep apnea (OSA) treatment will be assessed at baseline using the Self-Efficacy Measure for Sleep Apnea (SEMSA) questionnaire. The SEMSA is a validated self-report instrument with scores ranging from 1 to 4, where higher scores indicate greater self-efficacy (i.e., more confidence in using CPAP). The total score is continuous and will be analyzed as a predictor of CPAP adherence at 3 months. |
| Baseline anxiety levels (state and trait) | Baseline | Anxiety levels will be assessed at baseline using the State-Trait Anxiety Inventory (STAI), a validated self-report instrument consisting of two subscales: state anxiety and trait anxiety. Each subscale yields a score from 20 to 80, with higher scores indicating greater anxiety. Both scores will be analyzed separately as continuous predictors of CPAP adherence at 3 months. |
| Baseline personality traits | Baseline | Personality traits will be measured at baseline using the International Personality Item Pool - 50-item Short Form (IPIP-50). The IPIP-50 evaluates five personality traits: Openness, Conscientiousness, Extraversion, Agreeableness, and Neuroticism. Each trait score is derived from responses on a 1 to 5 Likert scale, with higher scores indicating a stronger presence of that trait. Each trait will be analyzed separately as a categorical or continuous predictor of CPAP adherence at 3 months. |
| Effect of motivational telephone intervention | From baseline to 3-month follow-up | Binary exposure variable (intervention: yes/no). CPAP adherence at 3 months will be compared between the intervention and control groups to assess the effect of the motivational telephone intervention. |
Countries
Croatia
Contacts
Primary ContactIvana Pavlinac Dodig, Assoc. Prof.
Outcome results
None listed