HIRREM Developmental Study

Wake Forest University (WFU)

Status: Completed

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

Treatments: Device: HIRREM

Study type: Interventional

Funder types: Other

Identifiers

NCT02709369

IRB00017651

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 11+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Active HIRREM

Experimental group

Description:

This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care.

Treatment:

Device: HIRREM