| NCT ID | NCT03777267 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Neurological Diseases or Conditions |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2019-04-12 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2019-04-12 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Charles Tegeler, MD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT03777267 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, studying Neurological Diseases or Conditions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03777267 currently recruiting?
Yes, NCT03777267 is actively recruiting participants. Contact the research team at BBRP@wakehealth.edu for enrollment information.
Where is the NCT03777267 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT03777267 clinical trial?
NCT03777267 is sponsored by Wake Forest University Health Sciences. The principal investigator is Charles Tegeler, MD at Wake Forest University Health Sciences. The trial plans to enroll 200 participants.