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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT03198494
Eligibility Criteria:
Inclusion Criteria:
* 18-60 years old
* Able to provide informed consent
* MOCA ≥26
* Fluent in English
* Frequent nocturnal IEDs (≥ 10% of the sleep record)
* Monitored on the adult epilepsy monitoring unit (EMU, for Aim 1 only) Additional inclusion criteria for Aim 3
* Frequent nocturnal seizures (≥1 per week)
Exclusion Criteria:
* Hearing impairment
* Diagnosis of a sleep disorder (sleep apnea, periodic limb movements of sleep, or other medical conditions with frequent arousals)
* Psychoactive medication use (other than AEDs, for example SSRIs, antipsychotics, BDZ, or stimulants)
* Seizures ≤ 24 hours prior to study.
* Alcohol or recreational drug use in the 24 hours prior to the study
* BMI ≥ 30
* MOCA \<26
* History of recent travel across time zones within the 1 month prior to study activities
* Shift work for 1 month prior to study activities Additional Exclusion Criteria for Aim 3
* No medication changes at least 1 month before study, and during 3 months of study activities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03198494
Study Brief:
Protocol Section:
NCT03198494