Nexalin Technology
A prospective, decentralized, individually-randomized, triple-blind\* sham-controlled, superiority trial to evaluate the safety and efficacy of HALO Clarity™ device in reducing insomnia severity. Participants will be randomized to Active and Sham device arms for four (4) weeks. After 4 weeks of treatment, all participants will be followed for an additional 4 weeks.
The HALO Clarity™ Transcranial Alternating Current Stimulation Therapy for Adults with Moderate-to-Severe Insomnia trial is a prospective, decentralized, individually-randomized, triple-blind, sham-controlled superiority study evaluating the safety and efficacy of the HALO Clarity™ device in adults with moderate-to-severe insomnia. The HALO Clarity™ device is a non-invasive cranial electrotherapy stimulator designed for at-home use. It delivers a proprietary alternating current waveform with an amplitude of 15 mA RMS, modulated at 77.5 Hz and superimposed on a 100 kHz carrier frequency. The d…
Inclusion Criteria 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.,…
The HALO Clarity™ Device is a non-invasive cranial electrotherapy stimulator designed for at-home use. It delivers a proprietary alternating current waveform with an amplitude of 15 mA RMS, modulated at 77.5 Hz and superimposed on a 100 kHz carrier frequency. Participants self-administer one 40-minute treatment session per day, five days per week, for four consecutive weeks (maximum of 20 sessions).
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