Wearable tES for Insomnia

Inclusion Criteria:

• Diagnosed with sleep onset insomnia
• Self report insomnia diagnosis (ISI score ≥15)
• 18-70 years old that are Tricare eligible
• untreated for insomnia with pharmacotherapy (if treated; they must stop treatment forat least 2 weeks prior to enrollment) treatment with nonpharmacotherapy (e.g. CBT) isallowable as long as the patient still meets other criteria for inclusion and thetreatment was discontinued >14 days prior to starting the study

Exclusion Criteria:

• Neurological Diagnosis including epileptic seizures; recent, multiple, or severeconcussion; traumatic brain injury; stroke; multiple sclerosis; or cognitiveimpairment with or without the use of prescription medication or requirement forhospitalization.
• Unstable psychiatric disorder requiring weekly clinical visits or medication changeswithin the last 4 weeks.
• History of neurodevelopmental disorder such as attention deficit hyperactivitydisorder, learning disability, or developmental delay
• Recent inpatient hospitalization for surgery and/or illness, ending within the last 6months.
• Hearing impairments requiring implanted or external devices for amplification.
• **Pregnant or believes there is a chance of pregnancy
• Current substance use disorder (addiction) within the past year, not includingnicotine
• Current use of narcotics (opioid based medications for the treatment of pain (OxyContin, Percocet, Vicodin, etc.) with or without a prescription within the lastyear
• Change in psychotropic (non sleep related) medications within the last 4 weeks (examples include: benzodiazepines, SSRI/SNRIs, bupropion, gabapentin).
• Consuming more than 10 alcoholic beverages per week
• Treatment for drug or alcohol use/abuse within the past 1 year
• Has sleep disorders that require treatment (e.g. CPAP for OSA), other than insomnia.
• Problems with motor coordination
• Cuts, scrapes, ingrown hairs, acne, razor burn, or scar tissue at the electrode sites.
• Tattoos on the head
• Non-removable metal anywhere in the body except bridges or fillings
• Any suicidal attempts within the last 12 months.
• Any other condition that the investigator believes would prevent completion of thestudy or put participant at risk
• Any suicidal ideations or thoughts of self-harm (as measured by the PHQ-9, Item 9)within the last 2 weeks
• Note: Pregnancy Safety data for tES use in pregnant women is scarce but isreviewed in: Antal, Andrea, et al. "Low intensity transcranial electricstimulation: safety, ethical, legal regulatory and application guidelines."Clinical neurophysiology 128.9 (2017): 1774-1809. The authors cite two casestudies of tES use in pregnant women with no impact or safety risk for the motheror fetus when tES was applied to the head at 2mA and 20-30 min per day. Therecommendation by the authors is to verbally enquire as to the pregnancy statusof the subjects and only deliver tES when the benefit outweighs risk. Here wepropose to completely exclude this population if the questionnaire reveals theyare pregnant or are trying to become pregnant. In the event that the patient isuntruthful regarding their pregnancy status we view the risk as insignificantgiven these reported studies and the fact that our dose is <¼ the dose used inthem. For this reason we have chosen not to perform a urine test to screen forpregnancy as we view it as an obtrusive and unnecessary step given the riskprofile.