NCT06378554

Cereset Research for Performance Improvement in a Hospital Nursing Unit

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Health Personnel
• Stress
• Anxiety
• Insomnia
• Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-02
• Primary completion: 2027-02-01
• Completion: 2027-07-01
• First posted: 2024-04-22
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study