N/A
N=144
Cereset Research In Healthcare Workers During COVID-19
Health Personnel · Stress · Anxiety · Insomnia · Hyperarousal
Bottom Line
View on ClinicalTrials.gov: NCT04682197 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Change in Perceived Stress Scale (PSS) — -7.8; -1.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cereset Research (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Perceived Stress Scale (PSS) |
-7.8; -1.2 | — |
| SECONDARY Change in Insomnia Severity Index (ISI) |
-6.3; -0.5 | — |
| SECONDARY Change in Generalized Anxiety Disorder-7 (GAD-7) |
-5.6; -1.3 | — |
Summary
The purpose of this study is to evaluate the use of Cereset Research to improve the symptoms of stress in healthcare workers in an open label, waitlist controlled pilot clinical trial, during the period of COVID-19.
Eligibility Criteria
Inclusion Criteria
- Employed Healthcare workers aged 18 years and older.
- Ability to comply with basic instructions and be able to sit still, comfortably during sessions.
- Subjects experiencing symptoms of stress who meet threshold scores the Perceived Stress Index (PSS, ≥ 14).
Exclusion Criteria
- Unable, unwilling, or incompetent to provide informed consent/assent.
- 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.
- Prior use of: HIRREM, HIRREM-SOP, Brainwave Optimization (BWO), Cereset, Cereset Home, or a wearable configuration of the same (B2, or B2v2).
- Prior use of: 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) within one month before enrollment.
- Known seizure disorder.
- Thoughts of suicide within the last 3 months.
- Current, significant symptoms of long-COVID.
- Current medical student.
Data sourced from ClinicalTrials.gov (NCT04682197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.