Cereset Research for Performance Improvement in a Hospital Nursing Unit

Depression Clinical Trial

Official title:

Cereset Research for Performance Improvement in a Hospital Nursing Unit

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378554
• Other study ID #: IRB00111227
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: May 2026

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: Dawn Higgins
• Phone: 3367169447
• Email: dkellar[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Health Personnel
• Insomnia
• Sleep Initiation and Maintenance Disorders
• Stress

Intervention

Device:
• Cereset Research
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.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Susanne Marcus Collins Foundation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of ortho trauma unit staff who complete Cereset intervention	Percent of ortho trauma unit staff who complete CR Intervention	up to 2 years