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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
View on ClinicalTrials.gov →
NCT03777267
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
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhaseN/A
SponsorWake Forest University Health Sciences
Started2019-04-12
Est. completion2026-04
Eligibility
Age11 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT03777267