What this study is
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.
What's being tested
- Cereset Research
Intervention · 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.
Study details
- Sponsor
- Wake Forest University Health Sciences
- Conditions
- Health Personnel · Stress · Anxiety · Insomnia · Depression
- Enrolling
- 40 people
- Starts
- 2024-07-02
- Est. completion
- 2027-07
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers AcceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Study team
Sponsor
Wake Forest University Health Sciences
Study ID IRB00111227
Principal investigator
Charles H Tegeler, MD
Wake Forest University Health Sciences
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.