Sleep Learning Education and Empowerment for Older Korean Immigrants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • CBT-I based sleep intervention

    Behavioral

    A multicomponent behavioral sleep program, consisting of sleep compression, stimulus control, sleep hygiene, relaxation, daily physical activity, and light exposure

  • Sleep Education

    Behavioral

    This group will receive information about sleep and aging, but without specific or individualized recommendations

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Sleep Intervention ProgramExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Immediately after the last session of the intervention
2

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)

Time frame
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

Time frame
Immediately after the last session of the intervention

Other outcomes

1

Feasibility of Recruitment

The number of participants approached who agreed to participate will be measured

Time frame
Immediately after enrolled
2

Feasibility of Randomization and Retention

The number of participants lost at a post-treatment assessment will be measured

Time frame
Immediately after enrolled
3

Adherence to 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

Time frame
Immediately after the last session of the intervention
4

Interventionist Adherence

The percentage of completion of delivery of each component in sessions throughout the intervention program will be measured

Time frame
Immediately after the last session of the intervention

Sponsors and contacts

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University of California, Los Angeles

Lead sponsor

National Institute on Aging (NIA)

Collaborator