Trials / Completed
CompletedNCT02709369
HIRREM Developmental Study
Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 11 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. This is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common denominator (heart rate variability, HRV), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.
Conditions
- Sleep Initiation and Maintenance Disorders
- Anxiety
- Post-Traumatic Stress Disorder
- Hot Flashes
- Headache
- Traumatic Brain Injury
- Post Concussion Symptoms
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HIRREM | HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neuro-technology to facilitate recipient-unique relaxation, auto-calibration, and self-optimization of cortical neural oscillations by reflecting auditory tones in near real time. After an initial HIRREM assessment, evaluating patterns of brain electrical rhythms, subjects get a series of 90-120 minute HIRREM sessions, including 5 to 9 individualized protocols. A protocol is a combination of sensor montage and specific software design, during which dominant brain frequencies, recorded at high spectral resolutions, are translated to audible tones, and reflected back via earphones with as little as 8 milliseconds delay. Protocols are received sitting or reclining in a chair, some with eyes open, others eyes closed. |
Timeline
- Start date
- 2011-08-23
- Primary completion
- 2018-10-25
- Completion
- 2018-10-25
- First posted
- 2016-03-16
- Last updated
- 2019-12-24
- Results posted
- 2019-12-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02709369. Inclusion in this directory is not an endorsement.