Cereset Research for Performance Improvement in a Hospital Nursing Unit

NCT06378554 | Enrolling By Invitation FDA Device

• 1 other identifier: IRB00111227
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore whether an implementation process composed of offering CR to staff in a single hospital nursing unit has any potential impact on unit-level quality measures post-implementation.

Conditions

Health Personnel; Stress; Anxiety; Insomnia; Depression

Keywords

Anxiety; Stress; Insomnia; Cereset Research; Brain electrical activity; Neurotechnology; HIRREM; Neuromodulation; Acoustic stimulation; Healthcare Worker

Outcome Measures

Primary Outcomes (1)

• Percent of ortho trauma unit staff who complete Cereset intervention

  Percent of ortho trauma unit staff who complete CR Intervention

  up to 2 years

Study Arms (2)

Cereset Intervention Group

ACTIVE COMPARATOR

This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM).

Device: Cereset Research

No Intervention

NO INTERVENTION

No Intervention

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 High-resolution, relational, resonance-based, electroencephalic mirroring (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 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:

• Ability to comply with basic instructions and be able to sit still, comfortably during sessions.
• Healthcare worker in the Orthopedic Trauma Unit at Atrium Health Wake Forest Baptist, aged 18 years and older.

You may not qualify if:

• Unable, unwilling, or incompetent to provide informed consent.
• Physically unable to come to the study visits.
• Severe hearing impairment (because CR involves acoustic stimulation that participants would need to be able to hear).
• Weight is over the chair limit (400 pounds).
• Currently enrolled in another Cereset Research study.
• 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). Individuals will be given the opportunity to discontinue these techniques for one month and then enroll.
• Known seizure disorder.
• Thoughts of active suicide within the last 3 months.

Sponsors & Collaborators

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

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Behavioral Symptoms; Behavior

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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: July 2, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)