Clinical trial NCT03479697: HIRREM for Stage 1 Primary Hypertension
Official title: High-Resolution, Relational, Resonance-Based, Electroencephalic Mirroring (HIRREM) for Stage 1 Primary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Blood Pressure
Cardiovascular Diseases
Cardiovascular Risk Factor
Autonomic Nervous System Imbalance
Keywords: HIRREM
Neurotechnology
Closed-Loop
Allostasis
Stress
Autonomic Dysregulation
Hyperarousal
Brain Electrical Activity
Acoustic Stimulation
Primary Hypertension
High Blood Pressure
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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 (systolic BP 130-139, and/or diastolic BP 80-89).

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Blood Pressure, as Measured by an Automated Oscillometric Blood Pressure Device.
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Secondary outcomes:
measure: Change in Heart Rate Variability (SDNN)
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in Baroreflex Sensitivity
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in Epworth Sleepiness Score (ESS)
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in PTSD Checklist for Civilians (PCL-C)
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in Perceived Stress Scale (PSS)
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in International Physical Activity Questionnaire (IPAQ-SF)
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in HIRREM Physical Activity Satisfaction Questions
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in Quality of Life Scale (QOLS)
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in Drop Stick Reaction Time
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
measure: Change in Grip Strength
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Other outcomes:
measure: Change in Alcohol Intake Screening (Audit-C)
timeFrame: Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).
Locations:
city: Winston-Salem
country: United States
facility: Department of Neurology, Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
References: