Cereset Research Exploratory Study
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.
Conditions:
🦠 Neurological Diseases or Conditions 🦠 Cardiovascular Conditions After Birth 🦠 Psychophysiologic Disorders
🗓️ Study Start (Actual) 12 April 2019
🗓️ Primary Completion (Estimated) January 2025
✅ Study Completion (Estimated) January 2026
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Winston-Salem, North Carolina, United States

📋 Eligibility Criteria

Description

    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).
    • * Anticipated and ongoing use of alcohol or recreational drugs.
    • * 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).
    • * 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.
Ages Eligible for Study: 11 Years to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 December 2018
  • First Submitted that Met QC Criteria 14 December 2018
  • First Posted 17 December 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 24 January 2024
  • Last Update Posted 26 January 2024
  • Last Verified September 2023