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NCT Number: NCT06994247

Boosting CPAP Use in Adults With Severe Sleep Apnea: Role of Motivation and Psychological Factors

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.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Split School of Medicine

Split, Dalmatia, 21000, Croatia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. CPAP Adherence After Three Months of Therapy

    Time frame: 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 outcomes

  1. Baseline self-efficacy related to OSA treatment

    Time frame: 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.

  2. Baseline anxiety levels (state and trait)

    Time frame: 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.

  3. Baseline personality traits

    Time frame: 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.

  4. Effect of motivational telephone intervention

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ivana Pavlinac Dodig, Assoc. Prof.

CONTACT

[email protected]

+38521557853

Sponsors and collaborators

Lead sponsor

University of Split, School of Medicine

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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