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Sleep therapy without pills: a new hope for older african americans?

NCT ID NCT06791356

Symptom relief Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether cognitive behavioral therapy for insomnia (CBT-I) can help older African Americans sleep better and think more clearly. Twenty participants will receive 8 weekly sleep training sessions via Zoom or a single education session. Researchers will measure sleep quality, thinking skills, and how well people stick with the program.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive-behavioral therapy for insomnia (CBT-I)
What this could lead to
If it works, this could point toward a practical, drug-free way to improve sleep and thinking in older African Americans with insomnia.
What could go wrong
This is a very small pilot study with only 20 people, so results may not apply to everyone. It is testing feasibility, not yet proven effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Older adults (65 years and older)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Rutgers University

    RECRUITING

    Newark, New Jersey, 07102, United States

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