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Идёт набор NCT07387406

Sleep Learning Education and Empowerment for Older Korean Immigrants

Без фазы С лечением Insomnia Chronic

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: CBT-I based sleep intervention, Sleep Education.
Кому может быть актуально
Состояния в реестре: Insomnia Chronic. Базовые параметры: от 60 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
США
Следующий шаг
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Официальное название

A Culturally Adapted Sleep Intervention Program for Older Asian Immigrants With Limited English Proficiency

Обзор

Poor sleep is common among Asian Americans. Untreated sleep problems increase the risk of chronic diseases, cognitive decline, and mortality. Cognitive behavioral therapy for insomnia (CBTI) is considered the first-line treatment for chronic sleep problems and has demonstrated significant improvement in sleep health among older adults. However, existing CBTI is built upon Western culture, making it challenging to apply for Asian immigrants who maintain close ties to their native cultures that shape and influence their sleep habits. Addressing the lack of availability of a culturally adapted sleep intervention program is the first step to filling the gap in sleep health disparity among Asian immigrants. This study aims to pilot test the feasibility and the preliminary efficacy of a culturally adapted sleep intervention program among older Korean immigrants with poor sleep, one of the fastest-growing immigrant groups in the United States with limited access to mainstream sleep therapies.

Подробное описание

Poor sleep is common among Asian Americans. Untreated sleep problems increase the risk of chronic diseases, cognitive decline, and mortality. Addressing the lack of availability of a culturally adapted sleep intervention program is the first step to filling the gap in sleep health disparity among Asian immigrants. This study aims to evaluate its feasibility and preliminary efficacy of a culturally adapted sleep education program ("SLEEP-OK") in a pilot randomized clinical trial. Study participant (N=32) will be randomized to either our culturally adapted, manual-based sleep intervention group (n=16) or the information-only control group (n=16) at our community partner serving older Korean immigrants. The study will evaluate the feasibility of the intervention and the preliminary effects of the intervention on sleep health outcomes among Korean immigrants at baseline and post-intervention (i.e., immediately after the last session of the intervention).

Вмешательства

  • Поведенческое CBT-I based sleep intervention
    A multicomponent behavioral sleep program, consisting of sleep compression, stimulus control, sleep hygiene, relaxation, daily physical activity, and light exposure
  • Поведенческое Sleep Education
    This group will receive information about sleep and aging, but without specific or individualized recommendations

Первичные конечные точки

  • Objective Sleep Efficiency [Срок оценки: Immediately after the last session of the intervention]
  • Subjective Sleep Quality [Срок оценки: Immediately after the last session of the intervention]
Вторичные конечные точки (1)
  • Acceptability of the Intervention [Срок оценки: Immediately after the last session of the intervention]

Критерии участия

Критерии включения

  • Korean immigrants (i.e., being a resident of the United States with a birthplace in Korea)
  • Able to speak, read, and write in Korean
  • Aged at least 60 years
  • Have a score of at least 15 on a Korean version of the Insomnia Severity Index
  • Able to ambulate with or without an assistive device
  • Have a score of at least 23 on a Korean version of the Montreal Cognitive Assessment (MoCA)
  • Score less than 5 on STOP-BANG (or proceed with an additional testing \[Watch Peripheral Arterial Tonometry (WatchPAT) and the Epworth Sleepiness Scale if score is equal to or greater than 5 on STOP-BANG)

Критерии исключения

  • Those who are bedbound
  • Those who do not meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for insomnia disorder
  • Those who have an untreated apnea-hypopnea index (AHI) at least 15 (moderate obstructive sleep apnea) and Epworth Sleepiness Scale (ESS) at least 11 (indicating mild sleepiness) OR AHI is equal to or greater than 30 (irrespective of ESS)

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
Двойное слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of California Los Angeles — Los Angeles

Идентификаторы

NCT: NCT07387406 · R21AG086817 · 1R21AG086817-01A1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗