Study of the Effects of HIRREM-SOP for Insomnia

High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM®) is a closed-loop, allostatic, acoustic stimulation neurotechnology that uses software-guided algorithmic analysis to identify and translate selected brain frequencies into audible tones to support real-time self-optimization of brain activity. Prior research demonstrates that the use of HIRREM is associated with reduced symptoms of insomnia, and traumatic stress and anxiety, and improved autonomic cardiovascular regulation across heterogeneous cohorts. HIRREM has been safe and well tolerated in about 500 people across six IRB-approved studies. However, the current in-office HIRREM approach remains very operator dependent (extensive Technologist education and experience) and takes a sizeable time commitment from the participant (typically ten or more sessions of 90-120 minutes each). To reduce participant time required, and operator dependence, while increasing scalability, a new generation of hardware and software has been developed. While based on the same core technology and algorithms to mirror brainwaves with audible tones, this includes the use of faster, 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols, all done with eyes closed (HIRREM-SOP). Although only 2 sensors are active at a time, applying 4 sensors, for which the software can switch from one pair to the other automatically, cuts in half the number of sensor placement changes needed, with reduced session time and interruptions. A modified placebo condition now includes random timing and pitch of the tones, which have not been acoustically engineered. This pilot study will evaluate feasibility of this standardized, enhanced approach, and the effectiveness of blinding for the placebo condition in participants with symptoms of insomnia.

Inclusion criteria

• Clinical Insomnia (Insomnia Severity Index ≥ 8) persisting by self-report for at least a month
• Subjects must have the ability to comply with basic instructions and be able to comfortably sit still with the sensor leads attached

Exclusion criteria

• Unable, unwilling, or incompetent to provide informed consent
• Physically unable to come to the study visits, or to sit in a chair for several hours
• Known seizure disorder
• Known obstructive sleep apnea
• Diagnosed periodic limb movement disorder or known restless legs syndrome
• Known urinary problem (i.e. benign prostatic hypertrophy) which is the likely cause of the sleep disturbance
• Severe hearing impairment (because the subject will be using ear buds during HIRREM-SOP)
• Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications (SSRI, or SNRI's), sleep medications such as zolpidem or eszopiclone, stimulants such as Adderall, Provigil, or Ritalin, or thyroid hormone
• Anticipated and ongoing use of recreational drugs, alcohol, or energy drinks
• Weight is over the chair limit (285 pounds)
• Currently in another active intervention research study
• Previous history of receiving or using HIRREM, BWO, HIRREM-SOP, or the wearable B2