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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT02709369
Eligibility Criteria:
Inclusion Criteria:
* Male and female adults and children aged 11 years and older.
* Subjects who are over the age of 18 must be able to give informed consent. Children must be able to sign an assent form and have a signed parental permission form.
* Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached.
* Subjects previously diagnosed with a neurologic, cardiovascular, or psychophysiological disease such as attention deficit hyperactivity disorder, Asperger Syndrome, chronic pain, dyslexia, depression, insomnia, migraines, anxiety, PTSD, substance abuse disorder, traumatic brain injury, and others.
Exclusion Criteria:
* Subjects who fail to meet inclusion criteria.
* Subjects who are unable, unwilling, or incompetent to provide informed consent, assent and/or parental permission.
* Subjects physically unable to come to the study visits.
* Subjects with a known seizure disorder.
* Subjects with severe bilateral hearing impairment (HIRREM requires the use of headphones).
* Subjects receiving ongoing treatment with opiate, benzodiazepine, anti-psychotic or sleep medications, as well as some anti-depressants or stimulants, except those cases deemed acceptable by the principal investigator.
* Subjects with anticipated and ongoing use of recreational drugs except when deemed acceptable by the principal investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Study:
NCT02709369
Study Brief:
Protocol Section:
NCT02709369