Cereset Research for Performance Improvement in a Hospital Nursing Unit

Not Applicable

• Conditions: Health Personnel; Stress; Anxiety; Insomnia; Depression
• Interventions: Device: Cereset Research

• Registration Number: NCT06378554
• Lead Sponsor: Wake Forest University Health Sciences

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.

Detailed Description

This is a pre-post design quality improvement project and implementation study, evaluating implementation measures, group level quality measures using QI methodology, and individual-level behavioral and performance measures before and after implementation of the Cereset Research (CR) evidence-based intervention among nursing unit staff. Individual-level behavioral symptoms and a nursing performance metric will be evaluated among healthcare workers in the nursing unit in the pre- and post-implementation timeframes among individuals who consent to participate in these evaluation activities. Up to 40 members of the unit will have the opportunity to enroll in the acoustic echoing neurostimulation intervention during the implementation timeframe. The neurostimulation intervention consists of 4 Cereset Research sessions of audible tones echoing current brainwave activity, and individual level behavioral symptoms will be collected following the last intervention session.

Study Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-22
• Study Start: 2024-07-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-02
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cereset Intervention Group	Cereset Research	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).

Primary Outcome Measures

Name	Time	Method
Percent of ortho trauma unit staff who complete Cereset intervention	up to 2 years	Percent of ortho trauma unit staff who complete CR Intervention

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States