HIRREM for Pre-Hypertension
Prehypertension, Blood Pressure, Autonomic Nervous System Imbalance
About this trial
This is an interventional treatment trial for Prehypertension focused on measuring HIRREM, Neurotechnology, Closed-loop, Acoustic stimulation, Allostatic, Heart rate variability, Baroreflex sensitivity, Blood pressure management, Autocalibration, Neural oscillations, Relaxation, Electroencephalic
Eligibility Criteria
Inclusion Criteria:
- Men and women, ≥ 18 years of age, with pre-hypertension, who have systolic BP ranging from 120-139 mm/Hg, or who have diastolic BP ranging from 80-89 mm/Hg.
Exclusion Criteria:
- Blood pressure values that are outside of the range for prehypertension at the enrollment visit.
- 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.
- Prior diagnosis of hypertension.
- Ongoing need for medical treatment for hypertension, or for the use of medications commonly used for treatment of hypertension.
- Known cardiovascular disease.
- Known seizure disorder.
- Known or anticipated pregnancy (females of childbearing age 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.
- Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
- Ongoing need for treatment with thyroid medications.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
HIRREM
Ambient Nature Sounds
Subjects in the experimental arm will receive an in-office, open-label course of acoustic stimulation linked to brain activity (High-resolution, relational, resonance-based, electroencephalic mirroring, HIRREM).
Subjects in the active comparator arm will receive an in-office, open-label course of acoustic stimulation not linked to brain activity (ambient natures sounds).