Status:
RECRUITING
Cereset Research Exploratory Study
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Neurological Diseases or Conditions
Cardiovascular Conditions After Birth
Eligibility:
All Genders
11+ years
Phase:
NA
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.
Detailed Description
The primary objective of this open label exploratory study is to evaluate the effect of CR to improve autonomic cardiovascular regulation in participants with symptoms of stress, anxiety, or insomnia....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03777267
Start Date
April 12 2019
End Date
April 1 2027
Last Update
July 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wake Forest University Health Scienc\ess
Winston-Salem, North Carolina, United States, 27157