HIRREM for Stage 1 Primary Hypertension

Wake Forest University (WFU)

Status: Completed

Conditions: Hypertension; Autonomic Nervous System Imbalance; Cardiovascular Diseases; Cardiovascular Risk Factor; Blood Pressure

Treatments: Device: HIRREM; Other: Continued Current Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03479697

IRB00047477

Details and patient eligibility

About

The purpose of this study is to determine that effects of an intervention called High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), on Stage 1 Primary Hypertension (systolic BP 130-139, and/or diastolic BP 80-89).

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

HIRREM

Active Comparator group

Description:

High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) is a novel, noninvasive, closed-loop, brainwave mirroring, acoustic stimulation neurotechnology to support relaxation and auto-calibration of neural oscillations, using auditory tones to reflect brain frequencies in near real time.

Treatment:

Other: Continued Current Care

Device: HIRREM

Continued Current Care

Other group

Description:

Participants will continue their current care.

Treatment:

Other: Continued Current Care

Device: HIRREM