Cereset Research Long-Term Healthcare Worker Study

NCT05994261 | Completed FDA Device

• 1 other identifier: IRB00099972
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stress; Anxiety; Autonomic Dysregulation; Acoustic Stimulation; Hyperarousal; Health Personnel

Keywords

stress; anxiety; insomnia; Cereset Research; hyperarousal; brain electrical activity; autonomic dysregulation; neurotechnology; HIRREM; allostasis; neuromodulation; acoustic stimulation; COVID-19; healthcare worker

Outcome Measures

Primary Outcomes (1)

• Change in Perceived Stress Scale (PSS) scores

  The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.

  Baseline to year 1

Secondary Outcomes (2)

• Change in Insomnia Severity Index (ISI) scores

  Baseline to year 1

• Change in Generalized Anxiety Disorder-7 (GAD-7) scores

  Baseline to year 1

Study Arms (2)

Cereset Research Tune-Up Intervention Group

ACTIVE COMPARATOR

All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will receive an additional tune-up (maintenance) session every 6 weeks for one year. There will be a CR session at weeks 6, 12, 18, 24, 30, 36, 42, and 48.

Device: Cereset Research

Cereset Research Control Group

OTHER

All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will continue their current care for 1 year with no additional CR sessions.

Device: Cereset Research

Interventions

Cereset Research DEVICE

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.

Cereset Research Control Group; Cereset Research Tune-Up Intervention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, comfortably during sessions.
• Experiencing symptoms of stress meeting threshold score on the Perceived Stress Scale (PSS ≥ 14).

You may not qualify if:

• 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 a chair 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, Cereset Research, 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, eye movement 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• The Susanne Marcus Collins Foundation, Inc.: collaborator

Study Sites (1)

Atrium Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Primary Dysautonomias; Sleep Initiation and Maintenance Disorders; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Autonomic Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Charles H Tegeler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: November 6, 2023
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)