HIRREM Developmental Study



Status:Completed
Conditions:Anxiety, Anxiety, Hot Flash, Insomnia Sleep Studies, Migraine Headaches, Neurology, Psychiatric, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology, Reproductive
Healthy:No
Age Range:11 - Any
Updated:12/5/2018
Start Date:August 23, 2011
End Date:October 25, 2018

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Functional and Physiological Effects of High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) for Neurological, Cardiovascular and Psychophysiological Disorders

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.


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.
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Principal Investigator: Charles H Tegeler, MD
Phone: 336-716-9447
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mi
from
Winston-Salem, NC
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