Cereset Research In Healthcare Workers During COVID-19

Study Overview
=================
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.

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.

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

Conditions
-----------------
Health Personnel, Stress, Anxiety, Insomnia, Hyperarousal, Corona Virus Infection, Covid19

Intervention / Treatment
-----------------
* Device: Cereset Research


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allostasis, Anxiety, Stress, Insomnia, Cereset Research, Hyperarousal, Brain electrical activity, Autonomic Dysregulation, Neurotechnology, HIRREM, COVID-19, Coronavirus, neuromodulation, acoustic stimulation, COVID, healthcare worker