Status:
COMPLETED
HIRREM for Stage 1 Primary Hypertension
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Hypertension
Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 (sy...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Adults, age 18 and above
- Systolic BP ranging from 130-139mmHg and/or diastolic BP ranging from 80-89mmHg
Exclusion
- 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
Key Trial Info
Start Date :
August 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03479697
Start Date
August 8 2018
End Date
November 13 2020
Last Update
April 20 2023
Active Locations (1)
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1
Department of Neurology, Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157