Health PersonnelNCT06378554
Cereset Research for Performance Improvement in a Hospital Nursing Unit
A study testing Cereset Research in people with Health Personnel and Stress, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Personnel, Stress, Anxiety
- What is being tested?
- Cereset Research
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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
- Being tested
- Cereset Research
- Keywords
- Anxiety, Stress, Insomnia, Cereset Research, Brain electrical activity, Neurotechnology, HIRREM, Neuromodulation, Acoustic stimulation, Healthcare Worker
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereset ResearchDevice
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 group | Role | What they receive |
|---|---|---|
| Cereset Intervention Group | Active comparator | 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). Receives: Device: Cereset Research |
| No Intervention | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of ortho trauma unit staff who complete Cereset intervention
Percent of ortho trauma unit staff who complete CR Intervention
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start2 Jul 2024
- Primary completionFeb 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PersonnelStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- The Susanne Marcus Collins Foundation, Inc.
- Responsible party
- Sponsor
- Investigators
- Charles H Tegeler, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378554
- Sponsor's protocol ID
- IRB00111227
- Status last verified
- Feb 2026
- First submitted
- 17 Apr 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cereset Research for Performance Improvement in a Hospital Nursing Unit
- ClinicalTrials.gov ID
- NCT06378554
- Acronym / sponsor ID
- IRB00111227
- Conditions
- Health Personnel, Stress, Anxiety, Insomnia, Depression
- Keywords
- Anxiety, Stress, Insomnia, Cereset Research, Brain electrical activity, Neurotechnology, HIRREM, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- The Susanne Marcus Collins Foundation, Inc.
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cereset Intervention Group | Active comparator | Device: Cereset ResearchThis 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). |
| No Intervention | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cereset ResearchThe 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. | Device | Cereset Intervention Group |
Primary outcome
Percent of ortho trauma unit staff who complete Cereset intervention
Time frame: up to 2 years
Percent of ortho trauma unit staff who complete CR Intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles H Tegeler, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cereset Research in people with Health Personnel and Stress, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of ortho trauma unit staff who complete Cereset intervention (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.