Cereset Research Exploratory Study
Wake Forest University Health Sciences
200 participants
Apr 12, 2019
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the use of Cereset Research to improve autonomic function in participants with symptoms of stress, anxiety, or insomnia.
Eligibility
Inclusion Criteria2
- 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 Criteria9
- 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.
Interventions
The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03777267