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 @ 10:39 PM
Ignite Modification Date:
2025-12-24 @ 10:39 PM
NCT ID:
NCT07183735
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* 18+ years old
* Self-reported issues with sleeping, falling asleep, or staying asleep.
* Willing to discontinue any supplements, medications, herbal remedies, or melatonin products used to assist with sleep for the study duration.
* Willing to avoid introducing any other supplements, medications, herbal remedies, or melatonin products used to assist with sleep for the duration of this trial.
* Willing to maintain their standard sleep pattern and activity level for the duration of the study.
* Be generally healthy and not live with any uncontrolled chronic disease.
Exclusion Criteria:
* Diagnosed with any chronic sleep condition, including but not limited to insomnia, narcolepsy, or sleep apnea.
* Women who are pregnant, breastfeeding, or trying to conceive.
* Anyone unwilling or unable to follow the study protocol.
* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Is currently undergoing, or planning to undergo, any significant medical procedures during the study period.
* Has undergone any surgeries or invasive treatments in the last six months.
* A history of severe allergic reactions, including but not limited to any of the product's ingredients.
* Anyone with a nut allergy.
* Heavy drinkers. A heavy drinker is considered to be a woman who drinks 8 or more alcoholic drinks per week or a man who drinks 15 or more alcoholic drinks per week.
* Anyone who uses illicit drugs.
* Use any prescription medication, over-the-counter, or herbal remedies that can affect sleep.
* Have a job that involves working the third or night shifts.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07183735
Study Brief:
Protocol Section:
NCT07183735