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Cereset Research Exploratory Study

RECRUITINGN/ASponsored by Wake Forest University Health Sciences
Actively Recruiting
PhaseN/A
SponsorWake Forest University Health Sciences
Started2019-04-12
Est. completion2026-04
Eligibility
Age11 Years+
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 11 Years+Healthy volunteers accepted
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.

Conditions4

AnxietyCardiovascular Conditions After BirthNeurological Diseases or ConditionsPsychophysiologic Disorders

Locations1 site

Wake Forest University Health Scienc\ess
Winston-Salem, North Carolina, 27157
Kenzie Brown336-716-9447BBRP@wakehealth.edu

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