RecruitingNot ApplicableNCT03777267

Cereset Research Exploratory Study

Sponsor

Wake Forest University Health Sciences

Enrollment

200 participants

Start Date

Apr 12, 2019

Study Type

INTERVENTIONAL

Conditions

Neurological Diseases or Conditions Cardiovascular Conditions After Birth Psychophysiologic Disorders

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

Min Age: 11 Years

Plain Language Summary

Simplified for easier understanding

This is an exploratory study testing a device called Cereset Research, which uses gentle sound tones to help the brain reset and reduce stress responses. The study is focused on people experiencing stress, anxiety, or insomnia to see whether this non-invasive brain stimulation technique can relieve symptoms. **You may be eligible if...** - You are able to follow simple instructions and sit comfortably with small sensors placed on your head - You are experiencing symptoms of stress, anxiety, or insomnia, scoring above a set threshold on self-reported questionnaires - You are willing to attend the required sessions **You may NOT be eligible if...** - You have certain neurological conditions that would make brain-based therapy unsafe - You are unable to sit still for the duration of the sessions - Your symptoms do not reach the minimum threshold scores required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive CR

The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.