Clinical trial NCT06994247: Boosting CPAP Use in Adults With Severe Sleep Apnea: Role of Motivation and Psychological Factors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Lead sponsor: University of Split, School of Medicine
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: CPAP Adherence After Three Months of Therapy
timeFrame: From baseline (enrollment) to 3-month follow-up
Secondary outcomes:
measure: Baseline self-efficacy related to OSA treatment
timeFrame: Baseline
measure: Baseline anxiety levels (state and trait)
timeFrame: Baseline
measure: Baseline personality traits
timeFrame: Baseline
measure: Effect of motivational telephone intervention
timeFrame: From baseline to 3-month follow-up
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University of Split School of Medicine
state: Dalmatia
Study officials:
References: