Nexalin is conducting a randomized, triple-blinded, sham-controlled study in collaboration with Lindus Health to advance its HALO Clarity therapy for severe insomnia. The study is designed to enroll a minimum of 150 participants across the U.S., including adults aged 22 to 65 with moderate to severe insomnia. Participants are expected to be randomized to receive either active HALO Clarity therapy or sham treatment for four weeks, followed by a four-week follow-up period to evaluate response durability.
Structured as a fully decentralized trial, participants will complete treatments and assessments remotely within Nexalin’s NeuroCare virtual clinic and its advanced Electronic Data Capture system. The NeuroCare virtual clinic is designed to eliminate traditional site visit requirements while expanding access to a broader patient population. This pivotal study supports the planned de novo insomnia submission to the FDA and represents a key milestone in Nexalin’s global strategy to expand its Deep Intracranial Frequency Stimulation platform into additional neuropsychiatric indications.
HALO Clarity Technology
HALO Clarity leverages Nexalin’s proprietary 15 mA DIFS technology, engineered to target deeper brain structures associated with sleep regulation and other mental health conditions. Unlike conventional transcranial stimulation approaches primarily targeting cortical regions, DIFS modulates deeper neural circuits implicated in sleep architecture, offering a potential non-pharmacological treatment alternative.
Insomnia affects approximately 30 million adults in the U.S., and the global insomnia therapeutics market represents a multi-billion-dollar annual opportunity that continues to grow as awareness and diagnosis increase. CEO Mark White stated that successful execution of this study and continued advancement along the FDA pathway will position Nexalin to pursue regulatory clearance in a high-demand market, further validate the broader potential of the technology, and support ongoing efforts to expand regulatory pathways across additional indications.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.benzinga.com/news/health-care/26/02/50810665/exclusive-penny-stock-nexalin-advances-pivotal-trial-aiming-to-tackle-severe-insomnia