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|NCT02709369 : HIRREM Developmental Study|
|Ages||Min: 11 Years Max: N/A|
- 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.
- 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
- 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.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02709369
| Link to official Clinicaltrials.gov listing