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

University of California, Los Angeles (UCLA)

Status: Begins enrollment this month

Conditions: Insomnia Chronic

Treatments: Behavioral: CBT-I based sleep intervention; Behavioral: Sleep Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07387406

R21AG086817 (U.S. NIH Grant/Contract)

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

Details and patient eligibility

About

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.

Full 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).

Enrollment: 32 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

Sleep Intervention Program

Experimental group

Description:

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

Treatment:

Behavioral: CBT-I based sleep intervention

Control

Placebo Comparator group

Description:

This involves with general information about sleep

Treatment:

Behavioral: Sleep Education