Exploring Cereset for improving stress and anxiety symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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
• Email: BBRP@wakehealth.edu
• Phone: 336-716-9447

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.