HIRREM Developmental Study

Completed · Not applicable

Conditions studied: Sleep Initiation and Maintenance Disorders, Anxiety, Post-Traumatic Stress Disorder, Hot Flashes, Headache, Traumatic Brain Injury, Post Concussion Symptoms

In brief

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.

Key facts

Study ID

NCT02709369

Run by

Wake Forest University Health Sciences

People needed

300

Starts

2011-08-23

Expected to finish

2018-10-25

Last updated by the study team

2019-12-24

Who can join

Age: 11 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Department of Neurology, Wake Forest School of Medicine — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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