Cereset Research Long-Term Healthcare Worker Study

Last updated: June 25, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Stress

Neurologic Disorders

Auditory Stimulation

Treatment

Cereset Research

Clinical Study ID

NCT05994261
IRB00099972
  • Ages 18-100
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Employed healthcare workers aged 18 years and older.

  • Have availability and interest in participating in a 1 year study.

  • Ability to comply with basic instructions and be able to sit still, comfortablyduring sessions.

  • Experiencing symptoms of stress meeting threshold score on the Perceived StressScale (PSS ≥ 14).

Exclusion

Exclusion Criteria:

  • No internet access, as some visits collected electronically

  • Unable, unwilling, or incompetent to provide informed consent.

  • Physically unable to come to the study visits, or to sit still, comfortably in achair for up to 1 hour.

  • Severe hearing impairment (because the subject will be using ear buds during CR).

  • Weight is over the chair limit (400 pounds).

  • Currently enrolled in another active intervention research study.

  • Prior use of: HIRREM, HIRREM-SOP, Brainwave Optimization (BWO), Cereset, CeresetResearch, Cereset Home, or a wearable configuration of the same (B2, or B2v2).

  • Prior use of the following modalities within one month before enrollment:electroconvulsive therapy (ECT), prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, eyemovement desensitization and reprocessing (EMDR), brain spotting, neurofeedback,biofeedback, or deep brain stimulation (DBS).

  • Known seizure disorder.

  • Thoughts of active suicide within the last 3 months.

  • Current medical student.

Study Design

Total Participants: 94
Treatment Group(s): 1
Primary Treatment: Cereset Research
Phase:
Study Start date:
November 06, 2023
Estimated Completion Date:
July 27, 2025

Study Description

This randomized, controlled study will evaluate the effects of long-term Cereset Research maintenance intervention in healthcare workers with symptoms of stress in the post era of COVID-19. Healthcare workers of all types have been impacted personally, professionally, and financially by the pandemic and its aftermath, resulting in higher levels of stress and anxiety. Additional, brief, noninvasive, non-drug strategies are needed to help mitigate the effects of the acute trauma associated with the pandemic. The primary outcome will be change in Perceived Stress Scale (PSS) a measurement of how different situations affect feelings and perceived stress in the Intervention group compared to the Control Group. Data will also be collected on a variety of additional relevant symptoms including insomnia, anxiety and autonomic cardiovascular regulation, for which benefits have been shown in prior studies using High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM). Data collected will assess the long-term effects of a low dose Cereset Research (CR) approach (only 4 sessions) and the importance of long-term maintenance intervention versus control. The Intervention Group will then receive 1 session every 6 weeks beginning 6 weeks after the 4 session bolus is completed. The Control Group continues current care with no additional CR sessions. A successful outcome of reduced stress at 1 year in the Intervention Group vs. Control Group would suggest benefit for long-term maintenance intervention sessions. The effect of this approach on autonomic function and other self-reported symptoms will also be explored. This information will be useful for determining intervention schedules for direct clinical implementation of the intervention. The proposed study might also help to identify characteristics of individuals who may experience differential effects/benefits from application of CR and determine if intermittent "tune-up" sessions may prolong symptom improvement.

Connect with a study center

  • Atrium Wake Forest Baptist Health

    Winston-Salem, North Carolina 27104
    United States

    Site Not Available

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