Cereset Research Exploratory Study

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Dec 14, 2018

Keywords

ClinConnect Summary

The Cereset Research Exploratory Study is looking into a new approach to help people who are dealing with stress, anxiety, or insomnia. The goal of this study is to see if a technique called Cereset Research can improve how the body's autonomic system functions, which plays a key role in managing stress and relaxation. The study is currently recruiting participants aged 18 and older, and it is open to all genders.

To be eligible for the study, participants need to be experiencing symptoms of stress, anxiety, or insomnia and should be able to follow simple instructions while comfortably sitting still for about 1.5 hours. If you or someone you know is interested, it's important to note that there are some exclusions, such as being unable to consent, having severe hearing issues, or being currently involved in another research study. Participants can expect to be part of a supportive environment where they will receive guidance and assistance throughout the process, while contributing to valuable research that may help improve mental well-being for others in the future.

Gender

ALL

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).
• • Anticipated and ongoing use of alcohol or recreational drugs.
• • 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).
• • 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.