HIRREM for Stage 1 Primary Hypertension

The purpose of this research study is to determine the effects of a technique called
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for
hypertension. HIRREM uses scalp sensors to monitor brain electrical activity, and computer
software algorithms translate selected brain frequencies into audible tones in real time.
Those tones are reflected back to participants via ear buds in as little as four to eight
milliseconds, providing the brain an opportunity for self-adjustment of its electrical
pattern.

This study will compare acoustic stimulation linked to brainwave activity (HIRREM, along with
continued current care, HCC), with continued current clinical care alone (CCC). Both groups
will continue their other current care throughout, including non-pharmacological, and
lifestyle modification therapies.

Inclusion Criteria:

- Adults, age 18 and above

- Systolic BP ranging from 130-139mmHg and/or diastolic BP ranging from 80-89mmHg

Exclusion Criteria:

- Unable, unwilling, or incompetent to provide informed consent

- Physically unable to come to the study visits, or to sit comfortably in a chair for up
to two hours at a time

- Weight is over the chair limit (285 pounds)

- Known atherosclerotic cardiovascular disease

- Cardiovascular risk score of ≥ 10% (per
http://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/)

- Prior diagnosis of stage 2 hypertension

- Ongoing need for treatment of hypertension with medications

- Known seizure disorder

- Known or anticipated pregnancy

- Severe hearing impairment (because the subject will be using headphones during the
interventions)

- Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications,
anti-depressant medications such as SSRI, SNRI, or tricyclic, and sleep medications
such as zolpidem or eszopiclone

- Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks

- Ongoing need for treatment with thyroid medications

- Are enrolled in another research study that includes an active intervention

- Have previously received brainwave optimization (BWO), used a B2 or B2v2 wearable
device, or previously participated in a HIRREM research study