Cereset Research In Healthcare Workers During COVID-19

NCT04682197 | Completed Results FDA Device

• 1 other identifier: IRB00066997
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health Personnel; Stress; Anxiety; Insomnia; Hyperarousal; Corona Virus Infection; Covid19

Keywords

Anxiety; Stress; Insomnia; Cereset Research; Hyperarousal; Brain electrical activity; Autonomic Dysregulation; Neurotechnology; HIRREM; COVID-19; Coronavirus; Allostasis; neuromodulation; acoustic stimulation; COVID; healthcare worker

Outcome Measures

Primary Outcomes (1)

• Change in Perceived Stress Scale (PSS)

  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.

  Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention

Secondary Outcomes (2)

• Change in Insomnia Severity Index (ISI)

  Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention

• Change in Generalized Anxiety Disorder-7 (GAD-7)

  Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention

Other Outcomes (9)

• Change in Center for Epidemiologic Studies Depression Scale (CES-D)

  Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention

• Change in Posttraumatic Stress Disorder (PTSD) Checklist for Civilians (PCL-C)

  Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention

• Change in Fatigue Severity Scale (FSS)

  Collected from baseline visit (V1) through completion of the primary data collection visit (V3), 4-7 weeks after completion of the intervention

Study Arms (2)

Cereset Research

ACTIVE COMPARATOR

For this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions.

Device: Cereset Research

Continued Current Care

OTHER

Participants will continue their current care.

Device: Cereset Research

Interventions

Cereset Research 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 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.

Cereset Research; Continued Current Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• The Susanne Marcus Collins Foundation, Inc.: collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104, United States

Location

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MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders; Coronavirus Infections; COVID-19; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Autonomic Nervous System Diseases

Results Point of Contact

• Title: Dr. Charles H. Tegeler
• Organization: Atrium Wake Forest Baptist Health

BBRP@wakehealth.edu

336-716-9447

Study Officials

• Charles H Tegeler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a single site, open label, randomized, waitlist controlled pilot clinical trial, enrolling healthcare workers aged 18 or older, who have self-reported symptoms of stress or anxiety, and meet a threshold score on self-reported inventories. Up to 166 participants will be enrolled in order to have at least 138 to complete the study. Participants will be randomly assigned to either an Early Intervention (EI) group which will receive 4 CR sessions of audible tones echoing current brainwave activity, following enrollment, or a Delayed Intervention (DI) group which will continue current care only, and will serve as a control group. Participants in both groups will continue their other current care throughout the study.

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 23, 2020
• Study Start: December 14, 2021
• Primary Completion: August 23, 2023
• Study Completion: October 10, 2023
• Last Updated: September 19, 2024
• Results First Posted: August 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)