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.
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.
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.
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.
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Investigator: Study Coordinator
Contact: 336-716-9447
BBRP@wakehealth.edu
Study Coordinator
336-716-9447
BBRP@wakehealth.edu
Charles H Tegeler, MD, Principal Investigator
Wake Forest University Health Sciences