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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT06510335
Eligibility Criteria:
Inclusion Criteria:
* Males and females, 35-50 years old
* Non-smokers
* Local to Pleasant Grove, Utah, and/or willing to come to clinical research center for study visits
* Willing and able to apply study products internally, topically and aromatically for about 6 weeks
* Willing to track use of study product on paper forms, via survey, or other means
* Willing to washout from all over-the-counter sleep aids, internally-consumed essential oils, alcohol, and lavender-based products for approximately 7 weeks
* Taking \<100 mg caffeine daily, and willing to avoid consumption of caffeine after 3pm
* Not working night shift or swing shift
* Not consistently traveling to other time zones (or willing to arrange schedule to avoid during study)
* No known medical condition or sensitivity which would make the application of these study products unsafe
* Own a smart device that can download and run the accelerometer application
* Willing and able to keep the same sleeping arrangements as much as possible throughout the study
* Willing to receive and respond to regular texts, emails, and/or phone calls from study staff
* No pregnancy within the last 60 days or currently breastfeeding (females)
* Not currently or previously participating in any other clinical trial within the last 30 calendar days
* Signed informed consent, HIPAA Authorization, and Confidentiality Agreement
* No major medical conditions (especially cardiac, lung, metabolic, cancer, or sleep) under the active care of a doctor
* No prescription medications that may interfere with sleep (e.g. attention deficit hyperactivity disorder stimulants, antihistamines, psychiatric drugs, sleep medications, narcotics, etc.)
* No evidence of medical condition, significant disease or disorder, medication, or surgery within the past 12 months that may, in the judgment of the medical reviewer, put the participant at risk or affect study results, procedures, or outcomes (e.g. obstructive sleep apnea, morbid obesity, cardiometabolic disease, cancer, lung-related conditions)
* Willing and able (in the opinion of the investigator) to comply with all study requirements and procedures
Exclusion Criteria:
* Failure to meet any of the above inclusion criteria
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
50 Years
Study:
NCT06510335
Study Brief:
Protocol Section:
NCT06510335