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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT03777267
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached
* Subjects experiencing symptoms of stress, anxiety, or insomnia, who meet threshold scores on one or more self-reported inventories for the same. This includes the Insomnia Severity Index (ISI, ≥ 8), the Perceived Stress Index (PSS, ≥ 14), or the Generalized Anxiety Disorder 7-item (GAD-7, ≥ 5) scale.
Exclusion Criteria:
* Unable, unwilling, or incompetent to provide informed consent/assent.
* Physically unable to come to the study visits, or to sit comfortably in a chair for up to 1.5 hours.
* Severe hearing impairment (because the subject will be using ear buds during CR).
* Weight is over the chair limit (285 pounds).
* Currently in another active intervention research study.
* Prior use of HIRREM, Brainwave Optimization, Cereset, or a wearable configuration of the same (B2, or B2v2) within the last 3 years.
* Prior use of electroconvulsive therapy (ECT).
* Prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, neurofeedback, biofeedback, or deep brain stimulation (DBS) within one month before enrollment.
* Known seizure disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Study:
NCT03777267
Study Brief:
Protocol Section:
NCT03777267