Status:
COMPLETED
HIRREM Developmental Study
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Sleep Initiation and Maintenance Disorders
Anxiety
Eligibility:
All Genders
11+ years
Phase:
NA
Brief 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 suppl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02709369
Start Date
August 23 2011
End Date
October 25 2018
Last Update
December 24 2019
Active Locations (1)
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1
Department of Neurology, Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157