Cereset Intervention for Stress and Anxiety

(LT-HW Trial)

Overseen By Charles H Tegeler, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Severe hearing impairment, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a treatment called Cereset Research, designed to help with stress and anxiety. Participants will first undergo four sessions of Cereset. One group will then receive an additional session every six weeks for a year, while the other group will continue with their usual care. This study suits healthcare workers experiencing stress who can sit comfortably for sessions and are interested in a year-long study. As an unphased trial, it offers a unique opportunity to explore a new approach to managing stress and anxiety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators.

What prior data suggests that Cereset Research is safe for stress and anxiety?

A previous study tested Cereset Research on 107 adults with insomnia. The study found the treatment safe and easy to handle, with participants reporting no serious issues. Another study involving military personnel showed changes in brain activity after using this technology, without mentioning any safety concerns. Overall, these studies suggest that Cereset Research is generally safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cereset intervention because it offers a non-invasive, drug-free approach to managing stress and anxiety, which sets it apart from standard treatments like medication and therapy. Unlike medications that alter brain chemistry, Cereset uses brainwave technology to help the brain rebalance itself naturally. This innovative method could lead to fewer side effects and a more personalized treatment experience, making it a promising alternative for those seeking relief from stress and anxiety.

What evidence suggests that Cereset might be an effective treatment for stress and anxiety?

Research has shown that Cereset Research, a non-invasive brain technology, can help reduce stress and anxiety. In earlier studies, participants reported feeling more rested, less tired, and experienced improved mood and clearer thinking. Another study found significant reductions in stress and sleep difficulties, along with better body responses to stress. In this trial, participants will be divided into two groups: the Cereset Research Tune-Up Intervention Group, which will receive additional maintenance sessions, and the Cereset Research Control Group, which will continue their current care without additional sessions. These findings suggest that Cereset might effectively lower stress and anxiety. ^{1 2 3 6 7}

Who Is on the Research Team?

Charles H Tegeler, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for healthcare workers over 18 who feel stressed (PSS score ≥ 14), can follow instructions, sit still for sessions, and commit to a year-long study. It's not for those without internet, severe hearing issues, over 400 pounds, using certain brain therapies recently or enrolled in another study.

Inclusion Criteria

I am available and interested in joining a study for 1 year.

I am an employed healthcare worker and I am 18 years or older.

I can follow simple instructions and sit still comfortably.

Exclusion Criteria

No internet access, as some visits collected electronically

I have a known seizure disorder.

I cannot sit comfortably for up to an hour or attend study visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Intervention

All participants receive an initial 4-session Cereset Research intervention

4 weeks

4 visits (in-person)

Maintenance Intervention

Intervention group receives a maintenance session every 6 weeks for one year

48 weeks

8 visits (in-person)

Follow-up

Participants are monitored for changes in stress, insomnia, and anxiety over one year

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cereset Research

Trial Overview

The trial tests long-term effects of 'Cereset Research', an acoustic stimulation therapy after initial sessions versus usual care. Participants are randomly assigned to either continue with the therapy or receive standard care after their first four sessions.

How Is the Trial Designed?

Group I: Cereset Research Control Group Experimental Treatment 1 Intervention

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.

Group II: Cereset Research Tune-Up Intervention Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

The Susanne Marcus Collins Foundation, Inc.

Collaborator

Trials

5

Recruited

430+

Susanne Marcus Collins Foundation, Inc.

Collaborator

Trials

2

Recruited

130+

Published Research Related to This Trial

A computer biofeedback game was developed to teach deep relaxation to 40 patients with irritable bowel syndrome (IBS), and most participants achieved deeper relaxation after just four 30-minute sessions, indicating the game's effectiveness in promoting relaxation.

About 50% of patients reported that using the relaxation technique during symptom flare-ups helped reduce their overall and bowel-specific symptoms, and 64% continued to use the technique long-term, suggesting its potential as a sustainable management strategy for stress-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised biofeedback games: a new method for teaching stress management and its use in irritable bowel syndrome. Leahy, A., Clayman, C., Mason, I., et al.[2022]

An online cognitive behavioral stress management intervention for early-stage breast cancer survivors significantly improved self-efficacy in coping with cancer and regulating negative mood after 10 weeks compared to a waitlist control group.

Participants in the intervention group also reported lower levels of cancer-related post-traumatic symptoms, indicating that this online approach can effectively support psychological well-being in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online stress management workbook for breast cancer. Carpenter, KM., Stoner, SA., Schmitz, K., et al.[2022]

Citations

1.

dcpsych.org

dcpsych.org/content.aspx?page_id=22&club_id=984812&module_id=656568&rkey=20251022PH04270&filter=9054

Clinical Study Reveals Cereset® BrainEcho™ Technology ...

The study revealed broad improvements: clients felt better rested, less fatigued, experienced improved mood, and sharper thinking. No serious ...

2.

cereset.com

cereset.com/research/

Cereset research

A Natural Non-invasive Neuro-technology Improves Sleep and Wellbeing in Randomized, Controlled Clinical Trial · Cereset Research Exposes the Secrets of Traumatic ...

3.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000206245

Cereset Research Reduces Symptoms of Stress, Insomnia, ...

The study was powered to detect a moderate clinically significant between-group difference in PSS score change at V3 (primary outcome).

4.

school.wakehealth.edu

school.wakehealth.edu/departments/neurology/brain-body-research-program/cereset-research/research-to-date

Research to Date - Cereset Research | Wake Forest University ...

We are committed to advancing our understanding of how Cereset® can improve autonomic function, alleviate symptoms of stress, anxiety, and insomnia, and enhance ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9933987/

Cereset Research Standard Operating Procedures for Insomnia

Among a cohort with military-related post-traumatic stress, reduced self-reported insomnia, post-traumatic stress, depression, anxiety symptoms, and improved ...

6.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/97/NCT04682197/Prot_SAP_000.pdf

Cereset Research to Reduce Stress in Healthcare Workers ...

Data and Safety Monitoring: The principal investigator will be responsible for the overall monitoring of the data and safety of study.

7.

morningstar.com

morningstar.com/news/pr-newswire/20251022ph04270/clinical-study-reveals-cereset-brainecho-technology-delivers-real-solutions-for-stress-anxiety-and-sleeplessness

Clinical Study Reveals Cereset® BrainEcho™ Technology ...

In this randomized controlled trial, participants facing moderate to high stress were assigned either to Cereset sessions or to a waitlist group ...