- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07387406
Sleep Learning Education and Empowerment for Older Korean Immigrants (SLEEP-OK)
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
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yeonsu Song, PhD
- Phone Number: 310-983-3029
- Email: ysong@sonnet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- University of California Los Angeles
-
Contact:
- Yeonsu Song, PhD
- Phone Number: 310-983-3029
- Email: ysong@sonnet.ucla.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
IPD Plan Description
IPD Sharing Time Frame
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
Studies a U.S. FDA-regulated device product
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.
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