Cranial Alternating Current Stimulation for Insomnia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a device called the HALO Clarity™, designed to help people with moderate-to-severe insomnia by reducing its severity. Participants will use the device at home for 40-minute sessions, five days a week, over four weeks. The trial compares the effects of the active device against a sham (inactive) device to determine its effectiveness in improving sleep. Individuals diagnosed with insomnia by a doctor and experiencing significant sleep issues may be suitable for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance sleep health.
What prior data suggests that the HALO Clarity™ device is safe for treating insomnia?
Research has shown that the HALO Clarity™ device, used to treat insomnia, is generally safe and well-tolerated. The device employs transcranial alternating current stimulation (tACS), which safely influences brain activity without surgery. Specifically, tests on the HALO Clarity™ device for insomnia have not reported any major safety concerns.
For instance, one study examined the safety of tACS in adults with insomnia and found no significant negative effects. Another report noted that similar devices, like the Alpha-Stim 100, are usually safe and easy to use, with few side effects. This evidence suggests that the HALO Clarity™ device is expected to be safe for participants.12345Why are researchers excited about this trial?
Unlike standard insomnia treatments, which often include medications like benzodiazepines or cognitive behavioral therapy, the HALO Clarity™ device offers a unique approach by using cranial alternating current stimulation. This device delivers a proprietary waveform that aims to modulate brain activity, potentially improving sleep without the side effects associated with medication. Researchers are excited about its non-invasive, at-home use, which makes it more convenient and accessible for patients. Additionally, its novel mechanism of action provides a fresh angle on tackling insomnia, which could lead to significant advancements in how we treat this common condition.
What evidence suggests that the HALO Clarity™ device is effective for reducing insomnia?
Studies have shown that cranial alternating current stimulation, a gentle electrical current applied to the brain, can improve sleep quality. Research indicates that this treatment can reduce the time to fall asleep by about 27 minutes and increase total sleep time by 47 minutes. Additionally, sleep efficiency improved by about 13%. The trial is studying the HALO Clarity™ device for its potential to treat insomnia. Participants in one arm will receive the active HALO Clarity™ device, while those in another arm will receive a sham device. Early findings suggest the active device could offer significant benefits. Similar treatments have proven effective for conditions like anxiety and depression, supporting the idea that it could also help with insomnia.678910
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the active or sham HALO Clarity™ device for 4 weeks, with one 40-minute session per day, 5 days per week
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Curavit Clinical Research
Collaborator
Citations
Nexalin Technology Enrolls First Patients and Advances ...
HALOTM Clarity devices will be deployed to ensure optimal patient coverage and data collection. The safety and efficacy of the HALOTM Clarity ...
Nexalin Technology, Inc. to Advance Pivotal Clinical Trial ...
Nexalin Technology announces a clinical trial for the HALO™ Clarity device aimed at treating moderate-to-severe insomnia.
A Meta-Analyses of Cranial Electrotherapy Stimulation in ...
Our results show that CES is an effective treatment for insomnia and a useful adjunctive to other ongoing treatments including pharmacotherapy ...
the Transcranial Alternating Current Dynamic Frequency ...
clinical studies have demonstrated therapeutic benefits in conditions ranging from treatment-resistant depression to migraines, anxiety, and ...
Treatment with Transcranial Alternating Current Stimulation
approximately 27-minute reduction in sleep an approximately 13% increase in sleep efficiency (SE), a 47-minute increase in total sleep time ( ...
Nexalin Technology Announces Issuance of U.S. Patent ...
Patent covers transcranial alternating current dynamic frequency stimulation methods for anxiety, depression and insomnia. Nexalin's HALOTM ...
Nexalin Technology, Inc. to Advance Pivotal Clinical Trial ...
HALOTM Clarity device aimed at treating moderate-to-severe insomnia. Q2 of 2026. tolerability concerns, dependency risk, side effects
Transcranial Alternating Current Stimulation (tACS) as a ...
This study aimed to examine the efficacy and safety of tACS for treating adult patients with chronic insomnia.
A sham-controlled study of HALO Clarity™ brain ...
HALO ClarityTM, can help adults who struggle with moderate-to-severe insomnia sleep better. Conditions: Moderate to Severe Insomnia Phase: Not Applicable
Cranial Electrotherapy Stimulation for Anxiety
Research has shown that the Alpha-Stim 100, a device for cranial electrotherapy stimulation (CES), is generally safe and easy to use. Studies have found that it ...
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