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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07311434
Eligibility Criteria:
Inclusion Criteria:
* Male or female.
* Age 25-59 years.
* BMI ≥18.5 and ≤29.9 kg/m².
* Currently experiencing issues with sleep quality, falling asleep, staying asleep, or waking during the night.
* RU-SATED score ≤17.
* Willing and able to follow the study protocol.
* Willing to discontinue any other supplements (including nootropics, adaptogens, calming herbs), medications, herbal remedies, or over-the-counter sleep medications (e.g., zolpidem, diphenhydramine, Benadryl, ZzzQuil, Unisom, magnesium or melatonin products) used to assist with sleep during the study.
* Agree to limit alcohol intake within approximately 4 hours of bedtime throughout participation.
* Agree to limit caffeine intake to ≤400 mg/day (about 3-4 cups of coffee) and avoid ingestion of caffeine-containing products after 2:00 PM during the study period.
* Generally healthy and not living with any uncontrolled chronic disease.
* Resides in the United States.
* Willing to discontinue any restricted products and adhere to all required study assessments.
Exclusion Criteria:
* Diagnosed chronic sleep conditions (e.g., insomnia, narcolepsy, REM Behavior Disorder, moderate to severe restless leg syndrome, sleep apnea).
* Current use of sleep-tracking technology (e.g., wrist-worn trackers, rings, smartphone apps) that could influence sleep behavior or perception.
Women currently undergoing perimenopause or experiencing vasomotor symptoms (e.g., night sweats).
* Use of hormone therapy (estrogen, progesterone, phytoestrogens) within the last 3 months.
* Diagnosed psychiatric disorders including major depressive disorder with acute symptoms, bipolar disorder, generalized anxiety disorder with active symptoms, and PTSD with frequent nightmares.
* Diagnosed neurodegenerative or chronic pain disorders, including Parkinson's disease, Alzheimer's disease, or uncontrolled fibromyalgia.
* Regular prescribed stimulant use (e.g., amphetamines such as Adderall/Vyvanse; methylphenidate such as Ritalin/Concerta; modafinil/armodafinil).
* Current use of CNS-activating antidepressants (bupropion, fluoxetine, venlafaxine, sertraline).
* Current or recent use of cannabis or THC-containing products (recreational or medicinal marijuana, CBD with measurable THC, synthetic cannabinoids) within the past 30 days.
* Employment in jobs disrupting nighttime sleep (e.g., night shift, rotating shift, excessive travel).
* Current use of prescription sleep aids.
* Introduction of any new sleep-related supplements, medications, herbal remedies, or melatonin products during the study.
* Use of any prescription or OTC products with sedative properties (e.g., melatonin, diphenhydramine, doxylamine, valerian, ZzzQuil, Advil PM) within 4 weeks prior to enrollment or habitual use ≥3 times per week prior to enrollment unless investigator-approved.
* Allergy or sensitivity to any study product ingredients.
* Pregnant, breastfeeding, or trying to conceive during the study period.
* History of substance abuse.
* Heavy alcohol use (≥8 drinks/week for women or ≥15 drinks/week for men).
* Participation in another research study now or within the next 7 weeks.
* Any condition or behavior that, in the investigator's judgment, may interfere with study participation or data integrity.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
59 Years
Study:
NCT07311434
Study Brief:
Protocol Section:
NCT07311434