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NCT06791356 · ClinicalTrials.gov registry record · NA
CBT-I in Older African American Adults
A NA study of Older Adults (65 Years and Older), sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06791356: Recruiting NA study of Older Adults (65 Years and Older), sponsored by Rutgers, The State University of New Jersey.
NCT06791356 is a NA study of Older Adults (65 Years and Older) that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 20 participants, below the 44-participant average among 4 other Older Adults (65 Years and Older) trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06791356, a NA study of Older Adults (65 Years and Older), is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 questionn
Primary Outcome
Number of sessions completed, sleep diary completion rate
Conditions Studied
Interventions
- BEHAVIORAL Sleep hygiene education
- BEHAVIORAL Cognitive-behavioral therapy for insomnia
Study Locations (1)
New Jersey
- Rutgers University - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-06-02 |
| Est. Completion | 2027-06 |
| Phase | NA |
What NCT06791356 shows while recruiting
NCT06791356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 44-participant average among 4 other Older Adults (65 Years and Older) trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Older Adults (65 Years and Older) appearing as the primary indexed condition, and to 2 interventions - of which Sleep hygiene education is the first listed.
NCT06791356 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT06791356 about?
NCT06791356 is a clinical study titled "CBT-I in Older African American Adults". 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 rec...
What is the current status of trial NCT06791356?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-06-02. Estimated completion is 2027-06.
What conditions does trial NCT06791356 study?
This clinical trial studies the following conditions: Older Adults (65 Years and Older).
What interventions are being tested in trial NCT06791356?
The interventions under investigation include: Sleep hygiene education (BEHAVIORAL), Cognitive-behavioral therapy for insomnia (BEHAVIORAL).
Who is sponsoring clinical trial NCT06791356?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06791356 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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