Cereset Research In Healthcare Workers During COVID-19

Cereset Research To Reduce Stress In Healthcare Workers In The Time Of COVID-19

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19; Stress; Insomnia; Anxiety; Corona Virus Infection; Health Personnel; Hyperarousal
• Intervention / Treatment: Device: Cereset Research

Detailed Description

The primary objective of this study is to evaluate the effect of CR to improve the Perceived Stress Scale (PSS) in healthcare workers with symptoms of stress, compared to waitlist control, at 4-6 weeks post intervention.

Secondary objectives include evaluating the effect of CR on the self-reported measures of sleep and anxiety. Exploratory measure include a variety of symptom inventories (mood, post-traumatic stress, quality of life, social support, and cognitive function), and autonomic cardiovascular regulation (heart rate variability, HRV).

Methods: This will be a single site, open label, randomized, waitlist controlled pilot clinical trial, enrolling adults 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.

The primary outcome will be interval change in The Perceived Stress Scale (PSS) which assesses the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Secondary outcomes include insomnia (Insomnia Severity Index, ISI) and anxiety (Generalized Anxiety Disorder-7, GAD-7). Exploratory outcomes to be collected include symptom inventories for depression (Center for Epidemiological Studies- Depression Scale, CES-D), traumatic stress (PTSD Checklist for civilians, PCL-C), overall quality of life (QOLS), social support (ISEL-12), the Multiple Ability Self-Report Questionnaire (MASQ) for cognitive function, Fatigue Severity Scale (FSS) for fatigue, and mental health (Depression, Anxiety, and Stress Scale, DASS -21). Details about COVID-19 status, interaction, workplace engagement, healthcare utilization, and exposure will be collected. Pre- and post-intervention data collection of physiological parameters (Heart rate, HR, and measures of autonomic cardiovascular regulation assessed by heart rate variability) will be assessed as exploratory outcomes.

All measures will be collected at an enrollment visit (V1), and participants will be randomly assigned to the EI or DI groups. For those in the EI group, the intervention will begin 0-7 days thereafter. Sessions will be administered over 10 days. Post-intervention data collections will be obtained at 0-7 days (V2) after completion of the intervention, and 4-6 weeks (V3, primary outcome) after the V2. Following V3, those in the DI group will be offered the opportunity to cross over to receive 4 CR sessions and will continue to be followed for data collections at 0-7 days (V4) after completing their sessions, and 4-6 weeks (V5) after V4. Because V4 and V5 are not required, these visits will be exploratory. Mean contrasts will be used to compare the changes in measures of autonomic cardiovascular regulation from V1 to V3, the primary outcome, as well as for exploratory outcomes. Linear mixed models, which can accommodate within-subject correlations due to repeated assessments over time, will be used to generate point estimates for effect size along with 95% confidence intervals.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 336-716-9447; Email: BBRP@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27104
      • Wake Forest Baptist Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Continued Current Care; Participants will continue their current care.	Device: Cereset Research; 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.
Active Comparator: Cereset Research; For this single arm, open label, exploratory trial this will be the intervention arm using 4 CR sessions.	Device: Cereset Research; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived Stress Scale (PSS)	The Perceived Stress Scale (PSS) 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. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.	Baseline
Change in Perceived Stress Scale (PSS)	The Perceived Stress Scale (PSS) 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. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.	Visit 2 (0-7 days after final session)
Change in Perceived Stress Scale (PSS)	The Perceived Stress Scale (PSS) 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. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Higher scores suggest increase perceived stress.	Visit 3 (4-6 weeks after V2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Insomnia Severity Index (ISI)	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.	Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)
Change in Generalized Anxiety Disorder-7 (GAD-7)	The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. Higher scores suggest increased anxiety.	Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Center for Epidemiologic Studies Depression Scale (CES-D)	The Center for Epidemiologic Studies Depression Scale (CES-D) is a depression scale, which will help to assess this co-morbidity. CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest increased depression.	Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)
Change in Posttraumatic stress disorder (PTSD) Checklist for Civilians (PCL-C)	The PTSD Checklist for civilians (PCL-C), measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, & D of PTSD symptoms based on traumatic life experience either in civilian life, or related to military service, respectively. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.	Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)
Change in Fatigue Severity Scale (FSS)	Fatigue Severity Scale (FSS) is a nine-item instrument to assess how fatigue interferes with daily activities. Items are scored on a 7-point scale ranging from 1=strongly disagree to 7=strongly agree. Total scores range from 9 to 63 and the higher the rating demonstrates greater fatigue severity .	Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)
Change in Quality of Life Scale (QOLS)	The Quality of Life Scale (QOLS) is a 16-item scale that was modified from a 15-item scale used in chronic disease patients. Topics include different components of daily life such as relationships, community engagement, personal fulfillment, and recreation. Each item is scaled from 1 to 7 and a sum score is calculated to represent higher levels of satisfaction in life (range is 16-112).	Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)
Change in Interpersonal Support Evaluation List (ISEL-12)	The Interpersonal Support Evaluation List - Shortened Version (ISEL-12) is a 12-item scale that was modified from a 40-item scale used to assess perceptions of social support. Three dimensions are evaluated: appraisal support, belonging support, and tangible support. Each item is scaled from 1 to 4 for "Definitely True" to "Definitely False." Scores are summed and higher scores correlate with more perceived social support.	Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)
Change in Multiple Ability Self-Report Questionnaire (MASQ)	The Multiple Ability Self-Report Questionnaire (MASQ) is a self-report questionnaire commonly used to assess perceived cognitive dysfunction. The MASQ has 38 items and assesses five cognitive domains, including language, visual/perceptual ability, verbal memory, visual memory, and attention.	Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)
Change in The Depression, Anxiety, and Stress Scale (DASS-21)	The Depression, Anxiety, and Stress Scale (DASS-21) is a self-report scale with 21 items(Le et al., 2019; D. Lee, 2019). These questions are divided into three subscales to depression, anxiety, and stress, respectively. The depression subscale scoring ranges from normal (0-9), mild depression (10-12), moderate depression (13-20), severe depression (21-27, and extremely severe depression (28-42). The anxiety subscale scoring ranges from normal (0-6), mild anxiety (7-9), moderate anxiety (10-14), severe anxiety (15-19), and extremely severe anxiety (20-42). The stress subscale ranges from normal (0-10), mild stress (11-18), moderate stress (19-26), sever stress (27-34), and extremely severe stress (35-42). This scale is routinely used in COVID-19 (Wang et al., 2020) and SARS literature(McAlonan et al., 2007).	Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)
Heart Rate Variability (HRV)	Measures of heart rate variability in frequency domain will be derived and measures integrated over specified frequency ranges (LF: 0.04-0.15 Hz; HF: 0.15-0.4 Hz). Power of RRI spectra in LF, HF range (LFRRI and HFRRI) and total power (TP) will be calculated in normalized units and ratio of LF/HF used as a measure of sympatho-vagal balance.	Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)
Change in Heart Rate (HR)	Continuous heart rate will be recorded while participant is breathing normally in seated position for 10 minutes using Faros 180 heart rate monitor (Bittium Corporation, Oulu, Finland). Beat to beat intervals (RRI) files will be generated at 1000 Hz via the data acquisition software. Files will be analyzed with Nevrokard HRV software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia). Recordings will be visually inspected to ensure data quality (dropped beats or gross motion artifacts are excluded) and first 5 minutes of usable tracings will be analyzed.	Baseline, V2 (0-7 days after final session), and V3 (4-6 weeks after V2)

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: The Susanne Marcus Collins Foundation, Inc
• Investigators: Principal Investigator: Charles H Tegeler, MD, Wake Forest University Health Sciences

Publications and helpful links

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Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Anxiety; Stress; Coronavirus; COVID-19; Insomnia; COVID; neuromodulation; healthcare worker; Neurotechnology; Autonomic Dysregulation; Hyperarousal; Allostasis; HIRREM; acoustic stimulation; Cereset Research; Brain electrical activity
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: IRB00066997

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes