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HIRREM for Pre-Hypertension

NCT03332043 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-03-07

No results posted yet for this study

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

Interventions

DEVICE

HIRREM

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.

OTHER

Ambient Nature Sounds

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

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Charles H Tegeler, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-31
Primary Completion
2018-10-31
Completion
2019-10-31
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03332043 on ClinicalTrials.gov