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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT04588233
Eligibility Criteria:
Inclusion Criteria:
* Self-identified sleep difficulties (e.g., difficulty falling asleep, staying asleep, or premature waking resulting in short or disrupted sleep).
* Ages 13 to 17 years old
* Able to understand, read, and write in English
* Melatonin naive
Exclusion Criteria:
* Obesity
* Use of psychiatric medication
* Drug(s), or supplements known to affect sleep
* History of head injury or concussion with loss of consciousness \>1 minute
* Daily consumption of \>1 caffeinated beverage
* Risk for any organic sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT04588233
Study Brief:
Protocol Section:
NCT04588233