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:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT06786494
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged ≥65 years
* Self-reporting insomnia (e.g., trouble sleeping approximately 3 nights a week for at least 6 months and/or an Insomnia Severity Index score ≥ 10 points)
* Usual bed-time between 8:00 pm and 1:00 am
Exclusion Criteria:
* Unwilling to follow the study protocol
* Inability to properly use the wearable device, complete smartphone-based surveys, or follow the intervention protocol
* Self-report of medically diagnosed sleep disorders except insomnia (e.g., sleep apnea)
* Current and consistent use of sleep aids or hypnotic prescriptions (e.g., trazadone)
* Self-report of cognitive impairment, dementia, or other neurological disorder
* Are on unstable medications (i.e., change within the last 3 months) for other conditions
* Have an allergy to the intervention products
* Self-report history of diabetes
* Current alcohol (Alcohol Use Disorders Identification Test ≥4 points33,34) or drug use disorder (Drug Abuse Screening Test,35,36 DAST-10\>2 points)
* Are excessive caffeine drinkers (\>5 cups of caffeinated beverages a day)
* Any other reason/condition the PI and investigative team believe this intervention would be unsafe
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06786494
Study Brief:
Protocol Section:
NCT06786494