HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia

Who can take part

• Participants must meet all of the following criteria to be eligible for the study:
• Provide written informed consent prior to any study-related procedures
• Age between 22 and 65 years, inclusive
• Total score on the Insomnia Severity Index (ISI) of ≥15 at screening, indicating moderate-to-severe insomnia
• Participant-reported diagnosis of insomnia, confirmed by a licensed clinician during the remote clinical evaluation call
• Willingness to be randomized to either the active or sham device arm
• Agreement not to use any sleep tracking devices or applications (e.g., smartwatches, sleep apps) during the study
• Ability to read and write English at an 8th-grade level or higher
• Ability to receive packages at home via standard delivery services (United States Postal Service, FedEx, or UPS) in all U.S. states except Alaska and Hawaii
• Willing and able to use a personal internet-capable mobile device throughout the study for completing questionnaires, using the HALO Clarity™ App, and receiving study-related text messages
• Owns and is willing to communicate using a personal, verifiable email address
• Able and willing to commit to one 40-minute treatment session using the HALO Clarity™ device, 5 days per week for 4 weeks (up to 20 sessions total)
• If currently using sleep medication, the regimen must have been stable for at least the past 3 months, with willingness to maintain the same medication and dosage throughout the study (no new sleep medications may be started during the trial)

Who cannot take part

• Use of any form of electronic brain stimulation or neuromodulation within the past 1 year (including cranial electrotherapy stimulation [CES], transcranial magnetic stimulation [TMS], electroconvulsive therapy [ECT], or deep brain stimulation)
• Institutionalization for a mental health condition within 1 year prior to study entry
• Implanted electronic device (e.g., pacemaker, defibrillator, deep brain stimulator, or cochlear implant)
• Use of recreational drugs, hypnotics, anabolic steroids, or marijuana products within the past 30 days, or planned use during the study (stable use of CBD is permitted)
• Presence of a current medical condition that, in the opinion of the Investigator or delegate, could impair reliable participation in the study or require the use of prohibited medications
• Current or history of alcohol or drug abuse or dependence within the past 5 years
• Under medical supervision for a serious medical condition (including, but not limited to, intracranial tumors or aneurysm)
• Suspected or known history of heart disease
• History of seizures or epilepsy
• History or current diagnosis of a chronic pain condition and/or use of opioids for any reason within the past 3 months
• Any other condition or circumstance that, in the opinion of the Investigator, would make the participant unsuitable for the study
• Participants who meet any of the following criteria will be excluded from the study:
• Females who are currently pregnant or planning to become pregnant during study participation
• Current participation in another investigational study, or participation in an investigational study within the past 30 days