Back to search results

Cereset Research for Stress, Anxiety, or Insomnia

This study is exploring Cereset Research (CR), a system that uses audible tones to echo your brainwaves in real-time. The goal is to see if CR can improve how your body regulates itself (autonomic function) if you experience stress, anxiety, or insomnia. Researchers will measure changes in your heart rate variability, blood pressure variability, and baroreflex sensitivity (how your body controls blood pressure) after 4-6 weeks. You may be able to join if you are 11 years or older, can follow basic instructions, and have symptoms of stress, anxiety, or insomnia that meet certain levels on self-reported questionnaires. The study is currently unclear on its recruitment status.

Study design
This is an open-label (meaning you and the researchers will know what treatment you are receiving) pilot study at a single location, aiming to enroll up to 200 participants.
What's involved
You will receive between 4 and 12 sessions of Cereset Research. You will continue your other current medical care throughout the study.
Compensation
Not stated in the trial record.
Follow-up
Your heart rate variability, baroreflex sensitivity, and blood pressure variability will be measured at baseline and again 4-6 weeks after your last treatment session.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03777267

Cereset Research Exploratory Study

Recruiting
NAAges 11+InterventionalSupportive care
Wake Forest University Health Sciences
~200 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Active CR

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Heart Rate Variability
Measured over Baseline, and V3 (4-6 weeks after V2)
+2 more outcomes measured

Conditions

Neurological Diseases or Conditions
Cardiovascular Conditions After Birth
Psychophysiologic Disorders

Explore related trials

AnxietyDysautonomiaInsomniaStress

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Charles Tegeler, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Kenzie Brown
[email protected]
336-716-9447
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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.

What this trial measures

  • Change in Heart Rate VariabilityBaseline, and V3 (4-6 weeks after V2)

    Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval (SDNN, milliseconds). For calculation of SDNN, the R-R intervals are visually inspected, and data considered as artifact is manually removed. Heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia). Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis.

  • Change in Baroreflex SensitivityBaseline, and V3 (4-6 weeks after V2)

    BRS calculated by this method is based on quantification of sequences of at least three beats (n) in which SBP consecutively increases (UP sequence) or decreases (DOWN sequence), which are accompanied by changes in the same direction of the RRI of subsequent beats (n+1). The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence. The mean of all individual regression coefficients (slopes), a measure of sequence BRS, is calculated for Sequence UP, DOWN and ALL (ms/mmHg). Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia).

  • Change in Blood Pressure VariabilityBaseline, and V3 (4-6 weeks after V2)

    Systolic BP and beat to beat, RR intervals (RRI) files generated via the data acquisition system (BIOPAC acquisition system and software, Santa Barbara, CA) at 1000 Hz are analyzed using Nevrokard SA-BRS software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia) for measures BPV.Frequency Method. Power spectral densities of SBP and RRI oscillations are computed by 512 points Fast Fourier Transform (FFT) and integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz).