HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia: A Prospective, Individually-Randomized, Triple-Blind, Sham-Controlled, Decentralized, Superiority Trial: 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.
Nexalin Technology
Summary
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.
Description
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…
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- Yes
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.,…
Interventions
- DeviceDevice: Transcranial alternating current stimulator
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 waveform is charge-balanced with no net direct current. The device consists of a wearable headset with three dry electrodes (one positioned on the forehead and two on the mastoid regions behind the ears). The headset connects via Bluetooth to a dedicated mobile application that controls treatment initiation, monitors electrode contact quality, displays session progress, and records usage data. Participants self-administer one 40-minute treatment session per day, five days per week, for four consecutive weeks (maximum of 20 sessions). Sessions may be performed at any time of day except within three hours before the participant's intended bedtime.
Location
- Nexalin TechnologyHouston, Texas