Clinical Trial Details
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NCT02709369 : HIRREM Developmental Study
AgesMin: 11 Years Max: N/A
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

- 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.
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