Boosting CPAP Use in Adults With Severe Sleep Apnea: Role of Motivation and Psychological Factors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Motivational Telephone Call.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea (OSA). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Phenotypic and Psychological Characteristics and a Motivational Telephone Intervention on Continuous Positive Airway Pressure (CPAP) Adherence in Patients With Severe Obstructive Sleep Apnea
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.
Interventions
- Behavioral Motivational 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, ide
Primary outcome measures
- CPAP Adherence After Three Months of Therapy [Time frame: From baseline (enrollment) to 3-month follow-up]
Secondary outcome measures (4)
- Baseline self-efficacy related to OSA treatment [Time frame: Baseline]
- Baseline anxiety levels (state and trait) [Time frame: Baseline]
- Baseline personality traits [Time frame: Baseline]
- Effect of motivational telephone intervention [Time frame: From baseline to 3-month follow-up]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Croatia · 1 center
- University of Split School of Medicine — Split
Identifiers
NCT: NCT06994247 · 2181-198-03-04-24-0107