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 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT03567395
Eligibility Criteria:
Inclusion Criteria:
Age: 18 - 55
* Male or female
* Able to comply with study protocol and give informed consent
* Healthy (no diagnosis of medical or mental illness) (not suffering from vascular disease, diabetes mellitus, hyperlipidemia, obesity (body mass index over 30), dermatological disease, gynecological disease, endocrine disease)
* Discontinuation of sleep aids 4 weeks in advance of the study
* Self-report of having difficulty sleeping for 1 week or more
Exclusion Criteria:
* Age: \<18 and \>55
* Type I and Type II diabetes, current infectious disease (e.g. cold or flu)
* Unstable medical condition
* History of psychiatric disorder (past or present)
* Pain syndrome affecting sleep
* Obese (BMI over 30)
* Pregnant or lactating women
* Lifestyle habits that would modify the wake-sleep rhythm (e.g. night work; shift work; young children that interrupt sleep)
* Substance and/or drug dependence (alcohol, nicotine, pain killers)?
* Use of the following medications during the study period: oral or injectable corticosteroid, sedating antihistamines (e.g. cold, allergy, motion sickness), psychotropic medications or hypnotics, benzodiazepine, narcotics, any illicit drugs
* Use of stimulants (\>4 cups (1 cup = 250 mL) of coffee/day)
* Participation in any other clinical trial with an investigational agent within one month prior to randomization
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03567395
Study Brief:
Protocol Section:
NCT03567395