Trials / Completed
CompletedNCT03479697
HIRREM for Stage 1 Primary Hypertension
High-Resolution, Relational, Resonance-Based, Electroencephalic Mirroring (HIRREM) for Stage 1 Primary Hypertension
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Hypertension
- Blood Pressure
- Cardiovascular Diseases
- Cardiovascular Risk Factor
- Autonomic Nervous System Imbalance
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HIRREM | Technology |
| OTHER | Continued Current Care | Continue their current clinical care. |
Timeline
- Start date
- 2018-08-08
- Primary completion
- 2020-11-13
- Completion
- 2020-11-13
- First posted
- 2018-03-27
- Last updated
- 2023-04-20
- Results posted
- 2023-04-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03479697. Inclusion in this directory is not an endorsement.