Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT03777267

Conditions

Neurological Diseases or Conditions

Cardiovascular Conditions After Birth

Psychophysiologic Disorders

Eligibility Criteria

Sex: All

Age: 11+

Healthy Volunteers: Not accepted

Interventions

Active CR

Study Details

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.

Conditions

Neurological Diseases or Conditions

Cardiovascular Conditions After Birth

Psychophysiologic Disorders

Study ID

NCT03777267

Start date

Apr 12, 2019

Status verified date

Jul, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Experimental: Active CR

For this single arm, open label, exploratory trial this will be the intervention arm using active CR.

Interventions

Active 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.

Primary outcome measure

  • Change in Heart Rate Variability [ Time Frame: Baseline, and V3 (4-6 weeks after V2) ]
  • Change in Baroreflex Sensitivity [ Time Frame: Baseline, and V3 (4-6 weeks after V2) ]
  • Change in Blood Pressure Variability [ Time Frame: Baseline, and V3 (4-6 weeks after V2) ]

Central Contacts and Locations

Central contacts

Kenzie Brown

336-716-9447BBRP@wakehealth.edu

Locations

Wake Forest University Health Scienc\ess

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Kenzie Brown

336-716-9447BBRP@wakehealth.edu

Principal Investigator:

Charles Tegeler, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Stress
  • Neurotechnology
  • Autonomic Dysregulation
  • Hyperarousal
  • Brain electrical activity
  • Allostasis
  • HIRREM
  • Cereset Research
  • Insomnia
  • Anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-20.