Insomnia ChronicSLEEP-OKNCT07387406
Sleep Learning Education and Empowerment for Older Korean Immigrants
A study testing CBT-I based sleep intervention and Sleep Education in people with Insomnia Chronic, run by University of California, Los Angeles at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- CBT-I based sleep intervention and Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2026to 4 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Los Angeles
Los Angeles, California, 90095
Yeonsu Song, PhD, 310-983-3029, ysong@sonnet.ucla.edu
About this study
Official title: 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.
Read the 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).
- Conditions
- Insomnia Chronic
- Being tested
- CBT-I based sleep intervention, Sleep Education
- Keywords
- older Korean Americans, sleep, behavioral approach
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-I based sleep interventionBehavioural
A multicomponent behavioral sleep program, consisting of sleep compression, stimulus control, sleep hygiene, relaxation, daily physical activity, and light exposure
Sleep EducationBehavioural
This group will receive information about sleep and aging, but without specific or individualized recommendations
| Study group | Role | What they receive |
|---|---|---|
| Sleep Intervention Program | Experimental | This is a culturally adapted sleep education program built upon key components of cognitive behavioral therapy for insomnia (CBT-I) Receives: Behavioral: CBT-I based sleep intervention |
| Control | Placebo comparator | This involves with general information about sleep Receives: Behavioral: Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Sleep Efficiency
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)
Measured: Immediately after the last session of the intervention
Subjective Sleep Quality
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)
Measured: Immediately after the last session of the intervention
Secondary outcomes (1)
Acceptability of the Intervention
Focus group interviews will be conducted to collect the benefits and challenges of following the sleep intervention program
Measured: Immediately after the last session of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start24 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion4 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Yeonsu Song, PhD, RN, FNP, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387406
- Sponsor's protocol ID
- R21AG086817
- Other IDs
- 1R21AG086817-01A1
- Acronym
- SLEEP-OK
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Adapted Sleep Intervention Program for Older Asian Immigrants With Limited English Proficiency
- ClinicalTrials.gov ID
- NCT07387406
- Acronym / sponsor ID
- SLEEP-OK / R21AG086817
- Conditions
- Insomnia Chronic
- Keywords
- older Korean Americans, sleep, behavioral approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 4 Jan 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Intervention Program | Experimental | Behavioral: CBT-I based sleep interventionThis is a culturally adapted sleep education program built upon key components of cognitive behavioral therapy for insomnia (CBT-I) |
| Control | Placebo comparator | Behavioral: Sleep EducationThis involves with general information about sleep |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-I based sleep interventionA multicomponent behavioral sleep program, consisting of sleep compression, stimulus control, sleep hygiene, relaxation, daily physical activity, and light exposure | Behavioural | Sleep Intervention Program |
| Sleep EducationThis group will receive information about sleep and aging, but without specific or individualized recommendations | Behavioural | Control |
Primary outcome
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)
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)
1 secondary outcome
Acceptability of the Intervention
Time frame: Immediately after the last session of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I based sleep intervention and Sleep Education in people with Insomnia Chronic, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeonsu Song, PhD (310-983-3029, ysong@sonnet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Sleep Efficiency (time frame: Immediately after the last session of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.