N/A
N=5
HIRREM for Stage 1 Primary Hypertension
Hypertension · Blood Pressure · Cardiovascular Diseases · Cardiovascular Risk Factor · Autonomic Nervous System Imbalance
Bottom Line
View on ClinicalTrials.gov: NCT03479697 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Change From Baseline in Blood Pressure, as Measured by an Automated Oscillometric Blood Pressure Device. — -3.00; -6.67; -6.00; -7.67 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HIRREM (Device); Continued Current Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Blood Pressure, as Measured by an Automated Oscillometric Blood Pressure Device. |
-3.00; -6.67; -6.00; -7.67 | — |
| SECONDARY Change in Heart Rate Variability (SDNN) |
17.55; 9.47 | — |
| SECONDARY Change in Baroreflex Sensitivity |
0.35; -4.97 | — |
| SECONDARY Change in Insomnia Severity Index (ISI) |
-3.00; -2.67 | — |
| SECONDARY Change in Pittsburgh Sleep Quality Index (PSQI) |
0; -1.33 | — |
| SECONDARY Change in Epworth Sleepiness Score (ESS) |
1.50; -0.67 | — |
| SECONDARY Change in Center for Epidemiologic Studies Depression Scale (CES-D) |
7.00; 1.33 | — |
| SECONDARY Change in Generalized Anxiety Disorder-7 (GAD-7) |
4.50; 1.00 | — |
| SECONDARY Change in PTSD Checklist for Civilians (PCL-C) |
6.00; -4.00 | — |
| SECONDARY Change in Perceived Stress Scale (PSS) |
5.50; -3.33 | — |
| SECONDARY Change in International Physical Activity Questionnaire (IPAQ-SF) |
0.00; 0.00 | — |
| SECONDARY Change in HIRREM Physical Activity Satisfaction Questions |
3.50; 2.00 | — |
| SECONDARY Change in Quality of Life Scale (QOLS) |
-4.00; 4.33 | — |
| SECONDARY Change in Drop Stick Reaction Time |
-0.06; -0.96 | — |
| SECONDARY Change in Grip Strength |
16.17; 0.00; -2.33; 2.44 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT03479697). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.