Cereset Research Exploratory Study
Recruiting · NCT03777267 · Interventional (participants receive a specific treatment) · Lead sponsor: Wake Forest University Health Sciences
View the official record on ClinicalTrials.gov →Interventions studied
Active CR
What this trial is about
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.
Who can take part
Age range
11 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Wake Forest University Health Scienc\ess - Winston-Salem, North Carolina, United States