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Идёт набор NCT06994247

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

Без фазы С лечением Obstructive Sleep Apnea (OSA)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Motivational Telephone Call.
Кому может быть актуально
Состояния в реестре: Obstructive Sleep Apnea (OSA). Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Хорватия
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • CPAP Adherence After Three Months of Therapy [Срок оценки: From baseline (enrollment) to 3-month follow-up]
Вторичные конечные точки (4)
  • Baseline self-efficacy related to OSA treatment [Срок оценки: Baseline]
  • Baseline anxiety levels (state and trait) [Срок оценки: Baseline]
  • Baseline personality traits [Срок оценки: Baseline]
  • Effect of motivational telephone intervention [Срок оценки: From baseline to 3-month follow-up]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Хорватия · 1 центр
  • University of Split School of Medicine — Split

Идентификаторы

NCT: NCT06994247 · 2181-198-03-04-24-0107

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗