RecruitingNot Applicable

Cereset Research Exploratory Study

United States200 participantsStarted 2019-04-12

Plain-language 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.

Who can participate

Age range

11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Heart Rate Variability

Timeframe: Baseline, and V3 (4-6 weeks after V2)

Change in Baroreflex Sensitivity

Timeframe: Baseline, and V3 (4-6 weeks after V2)

Change in Blood Pressure Variability

Timeframe: Baseline, and V3 (4-6 weeks after V2)

Trial details

NCT IDNCT03777267

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Kenzie Brown

336-716-9447 BBRP@wakehealth.edu

View on ClinicalTrials.gov More Neurological Diseases or Conditions trials

Who can participate

Age range

11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.