Clinical trial for Older Adults (65 Years and Older)
Official title CBT-I in Older African American Adults
ClinicalTrials.gov ID: NCT06791356
What this study is testing
- What it's testing
- The study wants to see if a CBT‑I program is doable and may improve sleep and thinking skills in older African American adults.
- Who it's for
- Adults 65 years or older who have trouble falling or staying asleep for at least a month.
- What's involved
- Participants will do 8 weekly Zoom sleep‑training sessions or one education session, fill out paper questionnaires, take cognitive tests, wear a wrist monitor for 7 days, and do two nights of home sleep recordings before and after the program.
- Time commitment
- The program lasts about 8 weeks, with follow‑up visits 3 months later for the same tests and recordings.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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.
You likely can't join if
- Currently taking any of the following medications consistently: Benzodiazepines (ProSom, Restoril, Ativan and Xanax)
- Diagnosed with any sleep disorder other than insomnia (i.e. obstructive sleep apnea using STOP-BANG, restless leg syndrome, REM sleep behavior...
- 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...
- Previous experience with CBT-I.
See the full eligibility 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.
- people must be willing to participate in 8 sessions of CBT-I via Zoom for the CBT-I group.
- people must be willing to come for pre/post assessment visits.
- MoCA score of between 20-26.
- Currently taking any of the following medications consistently: Benzodiazepines (ProSom, Restoril, Ativan and Xanax)
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Newark, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Newark, New Jersey, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.