Exploring Cereset for improving stress and anxiety symptoms

Cereset Research Exploratory Study

This study is testing whether a new treatment called Cereset can help people aged 11 and older who are dealing with stress, anxiety, or insomnia feel better by using sounds that match their brainwaves.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 11 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (other)
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT03777267 on ClinicalTrials.gov

What this trial studies

This exploratory study aims to evaluate the effects of Cereset Research (CR) on autonomic function in individuals experiencing stress, anxiety, or insomnia. Participants aged 11 and older will receive between 6 and 12 sessions of CR, which involves listening to audible tones that reflect their brainwave activity. The study will assess physiological outcomes such as blood pressure and heart rate variability, alongside self-reported symptom inventories. Additionally, it will explore the impact of medications and co-morbid conditions on the outcomes of CR.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 11 or older who report symptoms of stress, anxiety, or insomnia and meet specific threshold scores on self-reported inventories.

Not a fit: Patients with severe hearing impairment or those currently involved in another active intervention research study may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel non-invasive approach to alleviate symptoms of stress, anxiety, and insomnia.

How similar studies have performed: While the approach of using neurotechnology for autonomic regulation is innovative, similar studies have shown promise in addressing stress and anxiety through various non-invasive methods.

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.

Where this trial is running

Winston-Salem, North Carolina

• Wake Forest University Health Scienc\ess — Winston-Salem, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Charles Tegeler, MD — Wake Forest University Health Sciences
• Study coordinator: Kenzie Brown

Conditions: Neurological Diseases or Conditions, Cardiovascular Conditions After Birth, Psychophysiologic Disorders, Stress, Neurotechnology, Autonomic Dysregulation, Hyperarousal, Brain electrical activity