StressLT-HWNCT05994261
Cereset Research Long-Term Healthcare Worker Study
A study testing Cereset Research in people with Stress and Anxiety, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Autonomic Dysregulation
- 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
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2023to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Employed healthcare workers aged 18 years and older.
- Have availability and interest in participating in a 1 year study.
- Ability to comply with basic instructions and be able to sit still, comfortably during sessions.
- Experiencing symptoms of stress meeting threshold score on the Perceived Stress Scale (PSS ≥ 14).
Who cannot join
- No internet access, as some visits collected electronically
- Unable, unwilling, or incompetent to provide informed consent.
- Physically unable to come to the study visits, or to sit still, comfortably in a chair for up to 1 hour.
- Severe hearing impairment (because the subject will be using ear buds during CR).
- Weight is over the chair limit (400 pounds).
- Currently enrolled in another active intervention research study.
Show all 11Show fewer
- Prior use of: HIRREM, HIRREM-SOP, Brainwave Optimization (BWO), Cereset, Cereset Research, Cereset Home, or a wearable configuration of the same (B2, or B2v2).
- Prior 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).
- Known seizure disorder.
- Thoughts of active suicide within the last 3 months.
- Current medical student.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Wake Forest Baptist Health
Winston-Salem, North Carolina, 27104
About this study
Official title: Evaluating Long-Term Feasibility of Cereset Research for Stressed Healthcare Workers
Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus.
Read the detailed description
This randomized, controlled study will evaluate the effects of long-term Cereset Research maintenance intervention in healthcare workers with symptoms of stress in the post era of COVID-19. Healthcare workers of all types have been impacted personally, professionally, and financially by the pandemic and its aftermath, resulting in higher levels of stress and anxiety. Additional, brief, noninvasive, non-drug strategies are needed to help mitigate the effects of the acute trauma associated with the pandemic. The primary outcome will be change in Perceived Stress Scale (PSS) a measurement of how different situations affect feelings and perceived stress in the Intervention group compared to the Control Group. Data will also be collected on a variety of additional relevant symptoms including insomnia, anxiety and autonomic cardiovascular regulation, for which benefits have been shown in prior studies using High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM). Data collected will assess the long-term effects of a low dose Cereset Research (CR) approach (only 4 sessions) and the importance of long-term maintenance intervention versus control. The Intervention Group will then receive 1 session every 6 weeks beginning 6 weeks after the 4 session bolus is completed. The Control Group continues current care with no additional CR sessions. A successful outcome of reduced stress at 1 year in the Intervention Group vs. Control Group would suggest benefit for long-term maintenance intervention sessions. The effect of this approach on autonomic function and other self-reported symptoms will also be explored. This information will be useful for determining intervention schedules for direct clinical implementation of the intervention. The proposed study might also help to identify characteristics of individuals who may experience differential effects/benefits from application of CR and determine if intermittent "tune-up" sessions may prolong symptom improvement.
- Conditions
- Stress, Anxiety, Autonomic Dysregulation, Acoustic Stimulation, Hyperarousal, Health Personnel
- Being tested
- Cereset Research
- Keywords
- stress, anxiety, insomnia, Cereset Research, hyperarousal, brain electrical activity, autonomic dysregulation, neurotechnology, HIRREM, allostasis, neuromodulation, acoustic stimulation, COVID-19, healthcare worker
- Medical subject headings
- Anxiety Disorders, Primary Dysautonomias, Sleep Initiation and Maintenance Disorders, COVID-19
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 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 Research Tune-Up Intervention Group | Active comparator | All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will receive an additional tune-up (maintenance) session every 6 weeks for one year. There will be a CR session at weeks 6, 12, 18, 24, 30, 36, 42, and 48. Receives: Device: Cereset Research |
| Cereset Research Control Group | Other | All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will continue their current care for 1 year with no additional CR sessions. Receives: Device: Cereset Research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale (PSS) Scores
The Perceived Stress Scale is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale, with answers rated from 0-4, yields scores ranging from 0-40. Higher scores suggest increase perceived stress.
Measured: Baseline to year 1
Secondary outcomes (2)
Change in Insomnia Severity Index (ISI) Scores
The severity of insomnia symptoms is measured using two self-report symptom inventories with each data collection visit. This includes the Insomnia Severity Index (ISI). The ISI is a 7-question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28. The higher the score, the more suggestive of insomnia.
Measured: Baseline to year 1
Change in Generalized Anxiety Disorder-7 (GAD-7) Scores
The Generalized Anxiety Disorder-7 is a seven-item screening tool for anxiety, with answer ranging from 0-3, yielding total scores from 0-21. This is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety.
Measured: Baseline to year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start6 Nov 2023
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Single group
- Model description
- Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus.
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
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
- NCT05994261
- Sponsor's protocol ID
- IRB00099972
- Acronym
- LT-HW
- Status last verified
- Jun 2025
- First submitted
- 8 Aug 2023
- Last updated
- 21 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Long-Term Feasibility of Cereset Research for Stressed Healthcare Workers
- ClinicalTrials.gov ID
- NCT05994261
- Acronym / sponsor ID
- LT-HW / IRB00099972
- Conditions
- Stress, Anxiety, Autonomic Dysregulation, Acoustic Stimulation, Hyperarousal, Health Personnel
- Keywords
- stress, anxiety, insomnia, Cereset Research, hyperarousal, brain electrical activity, autonomic dysregulation, neurotechnology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- The Susanne Marcus Collins Foundation, Inc.
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Posted 21 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus.
Detailed description
This randomized, controlled study will evaluate the effects of long-term Cereset Research maintenance intervention in healthcare workers with symptoms of stress in the post era of COVID-19. Healthcare workers of all types have been impacted personally, professionally, and financially by the pandemic and its aftermath, resulting in higher levels of stress and anxiety. Additional, brief, noninvasive, non-drug strategies are needed to help mitigate the effects of the acute trauma associated with the pandemic. The primary outcome will be change in Perceived Stress Scale (PSS) a measurement of how different situations affect feelings and perceived stress in the Intervention group compared to the Control Group. Data will also be collected on a variety of additional relevant symptoms including insomnia, anxiety and autonomic cardiovascular regulation, for which benefits have been shown in prior studies using High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM). Data collected will assess the long-term effects of a low dose Cereset Research (CR) approach (only 4 sessions) and the importance of long-term maintenance intervention versus control. The Intervention Group will then receive 1 session every 6 weeks beginning 6 weeks after the 4 session bolus is completed. The Control Group continues current care with no additional CR sessions. A successful outcome of reduced stress at 1 year in the Intervention Group vs. Control Group would suggest benefit for long-term maintenance intervention sessions. The effect of this approach on autonomic function and other self-reported symptoms will also be explored. This information will be useful for determining intervention schedules for direct clinical implementation of the intervention. The proposed study might also help to identify characteristics of individuals who may experience differential effects/benefits from application of CR and determine if intermittent "tune-up" sessions may prolong symptom improvement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled study of long-term maintenance Cereset Research after an initial 4-session intervention bolus versus usual care control following an initial 4-session intervention bolus.
| Arm | Type | Receives |
|---|---|---|
| Cereset Research Tune-Up Intervention Group | Active comparator | Device: Cereset ResearchAll study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will receive an additional tune-up (maintenance) session every 6 weeks for one year. There will be a CR session at weeks 6, 12, 18, 24, 30, 36, 42, and 48. |
| Cereset Research Control Group | Other | Device: Cereset ResearchAll study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will continue their current care for 1 year with no additional CR sessions. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Employed healthcare workers aged 18 years and older.
- Have availability and interest in participating in a 1 year study.
- Ability to comply with basic instructions and be able to sit still, comfortably during sessions.
- Experiencing symptoms of stress meeting threshold score on the Perceived Stress Scale (PSS ≥ 14).
Key exclusion criteria (11 listed)
- No internet access, as some visits collected electronically
- Unable, unwilling, or incompetent to provide informed consent.
- Physically unable to come to the study visits, or to sit still, comfortably in a chair for up to 1 hour.
- Severe hearing impairment (because the subject will be using ear buds during CR).
- Weight is over the chair limit (400 pounds).
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 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 Research Control Group, Cereset Research Tune-Up Intervention Group |
Primary outcome
Change in Perceived Stress Scale (PSS) Scores
Time frame: Baseline to year 1
The Perceived Stress Scale is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale, with answers rated from 0-4, yields scores ranging from 0-40. Higher scores suggest increase perceived stress.
2 secondary outcomes
Change in Insomnia Severity Index (ISI) Scores
Time frame: Baseline to year 1
Change in Generalized Anxiety Disorder-7 (GAD-7) Scores
Time frame: Baseline to year 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
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 Stress and Anxiety, 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 21 Sep 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?
Yes. Results are posted in the registry (first posted 21 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Perceived Stress Scale (PSS) Scores (time frame: Baseline to year 1). 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 21 Sep 2026.