HIRREM for Stage 1 Primary Hypertension

NCT03479697 | Completed Results FDA Device

• 1 other identifier: IRB00047477
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Blood Pressure, as Measured by an Automated Oscillometric Blood Pressure Device.

  BP will be obtained in the left arm, with the participant sitting comfortably, and the left arm resting on a desk/table. Three samples will be obtained and the last two averaged to get the value that will be used as the reading. Primary outcome will be at V3 (4-6 weeks post final session).

  Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).

Secondary Outcomes (14)

• Change in Heart Rate Variability (SDNN)

  Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).

• Change in Baroreflex Sensitivity

  Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).

• Change in Insomnia Severity Index (ISI)

  Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).

• Change in Pittsburgh Sleep Quality Index (PSQI)

  Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).

• Change in Epworth Sleepiness Score (ESS)

  Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).

Other Outcomes (1)

• Change in Alcohol Intake Screening (Audit-C)

  Baseline to V3 (4-6 weeks following completion of the intervention for HCC, 8-10 weeks after V1 for CCC).

Study Arms (2)

HIRREM

ACTIVE COMPARATOR

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.

Device: HIRREM; Other: Continued Current Care

Continued Current Care

OTHER

Participants will continue their current care.

Device: HIRREM; Other: Continued Current Care

Interventions

HIRREM DEVICE

Technology

Also known as: High-resolution, relational, resonance-based, electroencephalic mirroring, Brainwave Optimization

Continued Current Care; HIRREM

Continued Current Care OTHER

Continue their current clinical care.

Continued Current Care; HIRREM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, age 18 and above
• Systolic BP ranging from 130-139mmHg and/or diastolic BP ranging from 80-89mmHg

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Department of Neurology, Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases; Primary Dysautonomias; Essential Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Autonomic Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

We found that the blood pressure requirements and medication exclusions we originally set in place were very hard to meet and therefore, excluded many subjects.

Results Point of Contact

• Title: Charles Tegeler, MD
• Organization: Atrium Wake Forest Baptist Health School of Medicine

BBRP@wakehealth.edu

336-716-9447

Study Officials

• Charles Tegeler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: August 8, 2018
• Primary Completion: November 13, 2020
• Study Completion: November 13, 2020
• Last Updated: April 20, 2023
• Results First Posted: April 20, 2023

Record last verified: 2022-07

Locations

US (1)