跳至主要内容
临床试验/NCT07387406
NCT07387406招募中不适用

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

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2026年2月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
Objective Sleep Efficiency

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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)

研究组 & 干预措施

Sleep Intervention Program

Experimental

This is a culturally adapted sleep education program built upon key components of cognitive behavioral therapy for insomnia (CBT-I)

干预措施: CBT-I based sleep intervention (Behavioral)

Control

Placebo Comparator

This involves with general information about sleep

干预措施: Sleep Education (Behavioral)

结局指标

主要结局

Objective Sleep Efficiency

时间窗: Immediately after the last session of the intervention

Nighttime sleep efficiency (i.e., mean percent of time in bed spent asleep at nighttime) will be calculated from 7 consecutive days and nights of wrist actigraphy (Scores range from 0 to 100%, with higher values indicating better objective sleep quality)

Subjective Sleep Quality

时间窗: Immediately after the last session of the intervention

Total score on the Korean version of the Insomnia Severity Index (ISI) will be used as a measure of subjective sleep (Scores range from o to 18, with lower values indicating better subjective sleep quality)

次要结局

  • Acceptability of the Intervention(Immediately after the last session of the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeonsu Song, PhD, RN, FNP

Associate Professor

University of California, Los Angeles

研究点 (1)

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