High-resolution, Relational, Resonance-based, Electroencephalic Mirroring (HIRREM) to Relieve Insomnia

Insomnia is the most prevalent sleep disorder and is associated with significant psychosocial
and somatic pathology. Effective noninvasive interventions for insomnia are lacking.
High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), is a
noninvasive, brain feedback technology to facilitate relaxation and auto-calibration of
neural oscillations by using auditory tones to reflect brain frequencies in near real time.
An open label, randomized, crossover pilot trial showed that HIRREM was safe and effective,
with significant benefits for individuals with moderate to severe insomnia, based on
differential change with symptoms of insomnia (Insomnia Severity Index, ISI). This study will
extend those results in a larger cohort using a single blind, placebo controlled study
design.

Inclusion Criteria:

- Moderate to severe clinical insomnia (Insomnia Severity Index score of 15 or higher)

Exclusion Criteria:

- Unable, unwilling, or incompetent to provide informed consent

- Physically unable to come to the study visits

- Known obstructive sleep apnea

- Diagnosed periodic limb movement disorder or known restless legs syndrome

- Known seizure disorder

- Known urinary problem (i.e. benign prostatic hypertrophy) which is the likely cause of
the sleep disturbance

- Severe hearing impairment

- Known, or suspected diagnosis of post-traumatic stress disorder (PTSD)

- Known, relevant traumatic brain injury (TBI)

- Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications,
anti-depressant medications such as SSRI, SNRI, or tricyclics, and sleep medications
such as zolpidem or eszopiclone

- Anticipated and ongoing use of recreational drugs or alcohol

- Lack of internet or smart phone access