N/A
Completed N=300
HIRREM Developmental Study
Sleep Initiation and Maintenance Disorders · Anxiety · Post-Traumatic Stress Disorder · Hot Flashes
Source: ClinicalTrials.gov NCT02709369 ↗
Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: Heart Rate Variability Standard Deviation of NN Intervals (SDNN) — 44.41 milliseconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate Variability Standard Deviation of NN Intervals (SDNN) |
— | — |
| PRIMARY Heart Rate Variability (SDNN) |
54.82 | — |
| PRIMARY Baroreflex Sensitivity High Frequency (HF) Alpha |
— | — |
| PRIMARY Baroreflex Sensitivity Sequence Up |
— | — |
| PRIMARY Baroreflex Sensitivity Sequence Down |
— | — |
| PRIMARY Baroreflex Sensitivity Sequence All |
— | — |
| SECONDARY Center for Epidemiologic Studies Depression Scale (CES-D) |
8.91 | — |
| SECONDARY Euro Quality of Life--Five Dimension (EQ-5D) |
78.36 | — |
| SECONDARY Generalized Anxiety Disorder-7 (GAD-7) |
3.66 | — |
| SECONDARY Insomnia Severity Index (ISI) |
6.22 | — |
| SECONDARY Posttraumatic Stress Disorder Checklist (PCL-C) |
38.75 | — |
| SECONDARY Posttraumatic Stress Disorder Checklist (PCL) |
26.13 | — |
| SECONDARY Rivermead Post-Concussion Symptoms Questionnaire (RPQ) |
16.89 | — |
| SECONDARY Drop Stick Reaction Testing |
22.58 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female adults and children aged 11 years and older.
- Subjects who are over the age of 18 must be able to give informed consent. Children must be able to sign an assent form and have a signed parental permission form.
- Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached.
- Subjects previously diagnosed with a neurologic, cardiovascular, or psychophysiological disease such as attention deficit hyperactivity disorder, Asperger Syndrome, chronic pain, dyslexia, depression, insomnia, migraines, anxiety, PTSD, substance abuse disorder, traumatic brain injury, and others.
Exclusion Criteria
- Subjects who fail to meet inclusion criteria.
- Subjects who are unable, unwilling, or incompetent to provide informed consent, assent and/or parental permission.
- Subjects physically unable to come to the study visits.
- Subjects with a known seizure disorder.
- Subjects with severe bilateral hearing impairment (HIRREM requires the use of headphones).
- Subjects receiving ongoing treatment with opiate, benzodiazepine, anti-psychotic or sleep medications, as well as some anti-depressants or stimulants, except those cases deemed acceptable by the principal investigator.
- Subjects with anticipated and ongoing use of recreational drugs except when deemed acceptable by the principal investigator.
Data sourced from ClinicalTrials.gov (NCT02709369). 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. Informational only — not medical advice.