HIRREM for Stage 1 Primary Hypertension

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-08

Study Completion Date

2020-11-13

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Hypertension Blood Pressure Cardiovascular Diseases Cardiovascular Risk Factor Autonomic Nervous System Imbalance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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. The participants in the CCC group will be offered the opportunity to crossover and receive a course of HCC.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HIRREM

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.

Group Type ACTIVE_COMPARATOR

HIRREM

Intervention Type DEVICE

Technology

Continued Current Care

Intervention Type OTHER

Continue their current clinical care.

Continued Current Care

Participants will continue their current care.

Group Type OTHER

HIRREM

Intervention Type DEVICE

Technology

Continued Current Care

Intervention Type OTHER

Continue their current clinical care.

Interventions

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HIRREM

Technology

Intervention Type DEVICE

Continued Current Care

Continue their current clinical care.

Intervention Type OTHER

Other Intervention Names

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High-resolution, relational, resonance-based, electroencephalic mirroring Brainwave Optimization

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No