Cereset Research Exploratory Study
Wake Forest University Health Sciences
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.
Description
The primary objective of this open label exploratory study is to evaluate the effect of CR to improve autonomic cardiovascular regulation in participants with symptoms of stress, anxiety, or insomnia. The secondary objective is to evaluate the effect of CR on a variety of self-reported symptom inventories. Tertiary objectives are to explore the impact of selected medications on outcomes associated with use of CR, the effect size in subgroups of participants who also report specific co-morbid symptoms or conditions of interest, and any unexpected challenges or barriers for working with the sa…
Eligibility
- Age range
- 11+ years
- Sex
- All
- Healthy volunteers
- No
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 visit…
Interventions
- DeviceActive CR
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.
Location
- Wake Forest University Health Scienc\essWinston-Salem, North Carolina