HIRREM for Pre-Hypertension

NCT03332043 | Withdrawn FDA Device

• 1 other identifier: IRB00044598
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized, controlled clinical pilot trial will evaluate the effects associated with in-office use of closed-loop, acoustic stimulation neurotechnology (High-resolution, relational, resonance-based, electroencephalic mirroring; HIRREM), compared with acoustic stimulation not linked to brainwaves (ambient nature sounds), for participants with pre-hypertension. Data collection will occur at baseline, and at intervals after completion of the intervention. Outcomes include blood pressure, measures of autonomic cardiovascular regulation, behavioral symptom outcomes, quality of life, alcohol use, and functional performance measures. The primary outcome will be change in blood pressure from baseline to 4-6 weeks after intervention.

Conditions

Prehypertension; Blood Pressure; Autonomic Nervous System Imbalance; Cardiovascular Risk Factor; Cardiovascular Diseases; Brain Diseases

Keywords

HIRREM; Neurotechnology; Closed-loop; Acoustic stimulation; Allostatic; Heart rate variability; Baroreflex sensitivity; Blood pressure management; Autocalibration; Neural oscillations; Relaxation; Electroencephalic

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  Change in systolic and diastolic blood pressure

  Data used for analysis of primary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention

Secondary Outcomes (11)

• Insomnia Severity Index (ISI)

  Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention

• Pittsburgh Sleep Quality Index (PSQI)

  Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention

• Epworth Sleepiness Score (ESS)

  Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention

• Center for Epidemiologic Studies Depression Scale (CES-D)

  Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention

• Generalized Anxiety Disorder-7 (GAD-7)

  Data used for analysis of secondary outcome is collected at the enrollment visit, 1-7 days after the intervention is completed, 4-6 weeks after the intervention is completed, and 12-14 weeks after completion of the intervention

Study Arms (2)

HIRREM

EXPERIMENTAL

Subjects in the experimental arm will receive an in-office, open-label course of acoustic stimulation linked to brain activity (High-resolution, relational, resonance-based, electroencephalic mirroring, HIRREM).

Device: HIRREM

Ambient Nature Sounds

ACTIVE COMPARATOR

Subjects in the active comparator arm will receive an in-office, open-label course of acoustic stimulation not linked to brain activity (ambient natures sounds).

Other: Ambient Nature Sounds

Interventions

HIRREM DEVICE

HIRREM (Brain State Technologies, Scottsdale, AZ) is a closed-loop, allostatic, acoustic stimulation neurotechnology that uses software-guided algorithmic analysis to identify and translate selected brain frequencies into audible tones of varying pitch and timing, to support real-time self-optimization of brain activity.

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

HIRREM

Ambient Nature Sounds OTHER

Digitally recordings of various ambient nature sounds such as a stream, waterfall, ocean waves, or rainfall, are provided via ear buds.

Also known as: Wave Aid

Ambient Nature Sounds

Eligibility Criteria

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

You may qualify if:

• Men and women, ≥ 18 years of age, with pre-hypertension, who have systolic BP ranging from 120-139 mm/Hg, or who have diastolic BP ranging from 80-89 mm/Hg.

You may not qualify if:

• Blood pressure values that are outside of the range for prehypertension at the enrollment visit.
• 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.
• Prior diagnosis of hypertension.
• Ongoing need for medical treatment for hypertension, or for the use of medications commonly used for treatment of hypertension.
• Known cardiovascular disease.
• Known seizure disorder.
• Known or anticipated pregnancy (females of childbearing age will be tested for pregnancy prior to randomization).
• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Related Publications (1)

• Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.

  PMID: 23532171 BACKGROUND

Related Links

• HIRREM research webpage

MeSH Terms

Conditions

Prehypertension; Cardiovascular Diseases; Brain Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Charles H Tegeler, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 6, 2017
• Study Start: March 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2019
• Last Updated: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share