HIRREM Hot Flashes Study

The purpose of this research study is to determine the effects of a technique called
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®), for hot
flashes. 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:

- Women, age 40 and above

- Intact uterus and ovaries

- Have at least 5 hot flashes per day (with at least one being categorized as moderate
to severe, in a stable pattern for one month).

Exclusion Criteria:

- Less than 5 hot flashes per day

- Does not experience at least 1 moderate to severe hot flash per day

- 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

- Known seizure disorder

- Known or potential pregnancy (females with last menstrual period less than one year
from enrollment will be tested for pregnancy prior to randomization)

- 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

- Use of pharmaceuticals for treatment of vasomotor symptoms or any type of hormone
replacement therapy

- Use of supplements for improvement of vasomotor symptoms including but not limited to
black cohosh, soy isoflavone extract, and red clover leaf extract

- Menopausal symptoms resulting from, or associated with surgery, chemotherapy,
radiation, or use of other chemicals or medications

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

- Ongoing need for treatment with thyroid medications

- Weight is over the chair limit (285 pounds)

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

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