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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT05116605
Eligibility Criteria:
Inclusion Criteria:
* Male or female 18-50 years of age
Exclusion Criteria:
* Has a head diameter outside the range of 20.8-24 inches, or an approved head-mounted EEG device doesn't otherwise fit properly
* Exceeds 290 pounds in body weight
* Has photophobia (light sensitivity)
* Has epilepsy or is prone to seizures
* Has thyroid problems or has been medicated for thyroid issues
* Has a current lower body musculoskeletal injury
* Has a current injury requiring an irremovable cast
* Is pregnant or actively trying to become pregnant
* Has a known or diagnosed sleep disorder
* Females who have become menopausal or are exhibiting signs or symptoms of becoming perimenopausal
* Females who are unable to identify when their monthly menstrual period will occur
* Individuals who work during the night shift or have significantly abnormal sleep schedule
* Has undergone travel across more than two collective time zones in the last two weeks
* Individuals who intend to have any significant medical procedures scheduled to occur within 12 weeks of enrollment
* Individuals who have intentions, or have discussed with their doctor, about adding or making any alterations to their prescribed medications within 12 weeks of enrollment
* Individuals who have any travel plans or other obligations within 12 weeks of enrollment that would prevent them from completing study requirements and attending required laboratory visits
* Individuals who intend to make significant alterations to their sleeping patterns within 12 weeks of enrollment. This may include, but is not limited to, changes such as moving, getting a new mattress, having someone move in with them, etc.
* Does not meet the ACSM's guidelines for exercise prescription. This is defined as:
1. Presenting with an absolute contraindication OR
1. Has a known cardiovascular, pulmonary, renal, metabolic disease, or other chronic illness
2. Presents with symptoms indicating cardiovascular, pulmonary, renal, or metabolic disease
2. presenting with two or more relative contraindications
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05116605
Study Brief:
Protocol Section:
NCT05116605