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Enrolling by invitation NCT06378554

Cereset Research for Performance Improvement in a Hospital Nursing Unit

No phase Interventional Health Personnel Stress Anxiety Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cereset Research.
Who it may be relevant to
Registry conditions: Health Personnel, Stress, Anxiety, Insomnia. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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 se

Primary outcome measures

  • Percent of ortho trauma unit staff who complete Cereset intervention [Time frame: up to 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT06378554 · IRB00111227

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗