| NCT ID | NCT06791356 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Older Adults (65 Years and Older) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-06-02 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Sleep problems, like insomnia, are common in older African Americans. About 25% of older adults in the US have at least 2 symptoms of insomnia, such as having trouble falling asleep, staying asleep, or getting good sleep for a month or more. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a recommended non-pharmacological treatment for insomnia. Unlike medicines that might only help for a short time or have many side effects, CBT-I deals with the root causes of insomnia. It helps people change how they think and act about sleep, leading to better habits and attitudes. This can make sleep better for a long time, even after the treatment is over. While CBT-I is commonly used among adults with insomnia, its benefits among older adults and specifically older African American adults are not well understood. Thus, the current pilot study will investigate the feasibility of CBT-I in older African American adults and establish preliminary evidence for the potential benefit of CBT-I on sleep as well as cognition in this population. For this study, participants will be asked to complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, which collects specific sleep measures such as brain waves and sleep stage timing, and computer-based neuropsychological tests before and after intervention. Study interventions will consist of 8 weekly sleep training sessions via Zoom or a single session of education on strategies to improve sleep quality. Sleep training sessions will include education about strategies to improve sleep quality, changing thought process that contribute to insomnia, training the brain on the optimal sleep environment, and reducing sleep initially to establish a consistent sleep schedule before increasing sleep time. Three months after the post-intervention visit, participants will be asked to come back in for a follow-up evaluation which consists of complete pencil-and-paper questionnaires, psychological tests of cognition, 7-day actigraphy, 2 nights of at home sleep monitoring, and computer-based neuropsychological tests.
Eligibility Criteria
Inclusion Criteria: * Reading level 6th grade or better and can speak and understand English well. * Self-identify as African American or Black. * Ages 60 and over. * Score of \>2 in PSQI sleep duration, sleep disturbance, or overall sleep quality calculated components. * Participating in the "Pathways to Healthy Aging in African Americans" study. * Has established chronic insomnia issues for at least three months. * Subjects must be willing to participate in 8 sessions of CBT-I via Zoom for the CBT-I group. * Subjects must be willing to come for pre/post assessment visits. * MoCA score of between 20-26. Exclusion Criteria: * Currently taking any of the following medications consistently: Benzodiazepines (ProSom, Restoril, Ativan and Xanax); Z Drugs (eszopiclone (Lunesta), zaleplon (Sonata) and zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist); antidepressants that affect sleep (doxepin, mirtazapine, trazodone); antihistamines (diphenhydramine and doxylamine succinate); barbiturates (methohexital, pentobarbital, primidone, secobarbital). * Diagnosed with any sleep disorder other than insomnia (i.e. obstructive sleep apnea using STOP-BANG, restless leg syndrome, REM sleep behavior disorder, etc.). * Classified as high fall risk. * Primary causes for frequent awakenings are due to a medical condition that is not related to insomnia, such as chronic pain, urinary frequency, upper respiratory infection. * Previous experience with CBT-I.
Contact & Investigator
Mark Gluck, PhD
PRINCIPAL INVESTIGATOR
Rutgers University
Frequently Asked Questions
Who can join the NCT06791356 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Older Adults (65 Years and Older). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06791356 currently recruiting?
Yes, NCT06791356 is actively recruiting participants. Contact the research team at pw352@newark.rutgers.edu for enrollment information.
Where is the NCT06791356 trial being conducted?
This trial is being conducted at Newark, United States.
Who is sponsoring the NCT06791356 clinical trial?
NCT06791356 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Mark Gluck, PhD at Rutgers University. The trial plans to enroll 20 participants.