Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT06791356
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT06791356
Study Brief:
Protocol Section:
NCT06791356