Cranial Alternating Current Stimulation for Insomnia
What You Need to Know Before You Apply
What is the purpose of this 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.
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.
Who Is on the Research Team?
David Owens, M.D.
Principal Investigator
Nexalin Technology
Are You a Good Fit for This Trial?
This trial is for adults who have moderate-to-severe chronic insomnia. People with certain medical or psychiatric conditions, or those using treatments that could interfere with the study, may not be eligible.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- HALO Clarity™ device
Trial Overview
The study tests a device called HALO Clarity™, which uses gentle electrical currents on the scalp to help improve sleep. Participants are randomly assigned to either an active treatment group or a sham (placebo) group for 4 weeks, followed by another 4 weeks of observation.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Participants randomized to this arm will receive the active HALO Clarity™ device. The device delivers a proprietary alternating current waveform with an amplitude of 15 mA RMS, modulated at 77.5 Hz with a 100 kHz carrier frequency. Participants will self-administer one 40-minute treatment session per day, 5 days per week, for 4 weeks (up to 20 sessions total) using the device at home.
Participants randomized to this arm will receive a sham HALO Clarity™ device. The sham device is physically identical to the active device in appearance, hardware, electrode placement, and mobile application interface. However, it delivers a non-therapeutic modulation scheme (brief ramp-up and ramp-down pulses) designed to provide a similar sensory experience while lacking therapeutic neuromodulatory effect. Participants will self-administer one 40-minute treatment session per day, 5 days per week, for 4 weeks (up to 20 sessions total) using the device at home.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nexalin Technology
Lead Sponsor
Lindus Health
Industry Sponsor
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