A home headset device (HALO Clarity™) for reducing insomnia severity

You may qualify if

• 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).

You can't join if

• 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.
• 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.
• 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.
• Implanted electronic device (e.g., pacemaker, defibrillator, deep brain stimulator, or cochlear implant).
• 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.
• 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).
• 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.
• Any other condition or circumstance that, in the opinion of the Investigator, would make the participant unsuitable for the study.