Sleep Learning Education and Empowerment for Older Korean Immigrants (SLEEP-OK)

March 3, 2026 updated by: Yeonsu Song, PhD, RN, FNP, University of California, Los Angeles

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

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.

Study Overview

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep Intervention Program
This is a culturally adapted sleep education program built upon key components of cognitive behavioral therapy for insomnia (CBT-I)
A multicomponent behavioral sleep program, consisting of sleep compression, stimulus control, sleep hygiene, relaxation, daily physical activity, and light exposure
Placebo Comparator: Control
This involves with general information about sleep
This group will receive information about sleep and aging, but without specific or individualized recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Sleep Efficiency
Time Frame: 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)
Immediately after the last session of the intervention
Subjective Sleep Quality
Time Frame: 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)
Immediately after the last session of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of the Intervention
Time Frame: Immediately after the last session of the intervention
Focus group interviews will be conducted to collect the benefits and challenges of following the sleep intervention program
Immediately after the last session of the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Recruitment
Time Frame: Immediately after enrolled
The number of participants approached who agreed to participate will be measured
Immediately after enrolled
Feasibility of Randomization and Retention
Time Frame: Immediately after enrolled
The number of participants lost at a post-treatment assessment will be measured
Immediately after enrolled
Adherence to the Intervention
Time Frame: Immediately after the last session of the intervention
The total number of sessions and the percentage of days that participants met goals for recommendations throughout the intervention program will be measured
Immediately after the last session of the intervention
Interventionist Adherence
Time Frame: Immediately after the last session of the intervention
The percentage of completion of delivery of each component in sessions throughout the intervention program will be measured
Immediately after the last session of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 4, 2027

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • R21AG086817 (U.S. NIH Grant/Contract)
  • 1R21AG086817-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD difficulty masking the identity of participants will not be shared publicly. However, all de-identified data and metadata will be made available through National Sleep Research Resource (NSRR), an NHLBI-funded resource at the time of the associated publication or the end of this project year, whichever comes first. Final research data and metadata will be shared by the end of the project period or at the time of publication, whichever is sooner, and will remain accessible indefinitely.

IPD Sharing Time Frame

by the end of the project period or at the time of publication, whichever is sooner,

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insomnia Chronic

Clinical Trials on CBT-I based sleep intervention

Subscribe