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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Telephone Call - Intervention Group | Experimental | Participants in this group will receive standard CPAP therapy along with a motivational telephone intervention. Approximately one month after initiating CPAP therapy, a physician will contact participants by phone to assess usage and discuss any difficulties. During the call, the physician will provide personalized motivation and education regarding the health benefits of consistent CPAP use to enhance treatment adherence. Timing: At 1 month post-enrollment Delivered by: Medical doctor Mode: Telephone Goal: To improve CPAP adherence at the 3-month follow-up |
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| No Intervention - Control Group | No Intervention | Participants in this group will receive standard CPAP therapy only, without any additional motivational contact beyond routine clinical follow-up. Data on adherence will be collected at the 3-month time point using CPAP device memory cards. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Telephone Call | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP Adherence After Three Months of Therapy | CPAP adherence at three months, measured as the percentage of days with CPAP usage ≥4 hours per night, obtained from CPAP device memory cards. | From baseline (enrollment) to 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline self-efficacy related to OSA treatment | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivana Pavlinac Dodig, Assoc. Prof. | Contact | +38521557853 | ivana.pavlinac@mefst.hr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Split School of Medicine | Recruiting | Split | Dalmatia | 21000 | Croatia |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Baseline |
| Baseline anxiety levels (state and trait) | 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 |
| Baseline personality traits | 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. | Baseline |
| Effect of motivational telephone intervention | 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. | From baseline to 3-month follow-up |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |