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Clinical study demonstrated clinically meaningful and statistically significant improvements in key sleep parameters, compared to adult patients treated with placebo
Data published in Journal of Psychiatric Research suggests that the Gen-2 tACS device may have the potential to reduce chronic insomnia and consistently improve sleep quality and efficiency in adults
Chronic insomnia is often associated with fatigue, mood changes, difficulty concentrating and impaired daytime functioning
HOUSTON, TEXAS, March 06, 2024 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today announced positive results of a clinical study of its Gen-2 tACS device (“tACS”) for the treatment of chronic insomnia. This clinical study, conducted at Xuanwu Hospital of Capital Medical University in Beijing and Beijing Anding Hospital, evaluated the treatment response of 120 adult participants who were divided into two prespecified age subgroups.
Key data reported from the study suggests that tACS ameliorates chronic insomnia, and that age can impact the extent of the resulting improvement from tACS treatment. Older participants (ages 50 and over) experienced comparatively more significant benefits from tACS, in terms of enhanced sleep quality, efficiency and overall insomnia reduction (p < 0.001), relative to younger participants. This is attributed to the natural changes in sleep physiology that occur with aging and the distinct manifestations of insomnia symptoms in older individuals.
Chronic insomnia is characterized by difficulty in initiating or maintaining sleep, and early morning awakening, occurring at least three nights per week for at least three months, accompanied by daytime consequences such as fatigue, attention deficits, and emotional instability. As one of the most common sleep disorders, chronic insomnia has a high prevalence and incidence, with approximately 6%–10% of adults experiencing this condition worldwide.
The randomized, double-blind, placebo-controlled, parallel-group, multicenter study was conducted over a two-month period (comprised of four “active” weeks, immediately followed by four follow-up weeks) on patients in two prespecified age subgroups, ranging from 22 to 65 years old.
The clinical study’s results, which were published in the Journal of Psychiatric Research, showed that tACS meaningfully reduced the severity of insomnia and enhanced sleep quality and efficiency. This achievement was assessed across all key metrics including the Pittsburgh Sleep Quality Index (PSQI), sleep onset latency (SOL), total sleep time (TST), sleep efficiency, sleep quality, Hamilton Anxiety Rating Scale (HAMA), Hamilton Depression Rating Scale (HAMD), Clinical Global Impression Scale severity of illness (CGI-SI), Clinical Global Impression Scale global improvement (CGI-GI) and Clinical Global Impression Scale efficacy index (CGI-EI).
To review the study’s findings, go to: https://www.sciencedirect.com/science/article/abs/pii/S0022395623006015
Mark White, CEO of Nexalin Technology, stated, “We are encouraged by the results of the clinical study in patients with chronic insomnia, treated at two prestigious medical centers in China, which has been featured in a leading peer-reviewed journal. According to Market Data Forecast, the global insomnia market is valued at over $5 billion. However, this market is dominated by pharmacological therapies that often come with undesired side effects. The results of this latest study reinforce the growing body of clinical evidence supporting the significant impact of our neurostimulation device on improving mental healthcare outcomes among patients across a wide array of indications. Once again, no significant adverse effects were reported, which is especially noteworthy given the growing number of patients seeking more effective non-pharmacological treatment options. We remain committed to our mission of helping address the global mental health epidemic and look forward to further expanding our innovative neurostimulation devices into new indications.”
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to uniquely and effectively help combat the ongoing global mental health epidemic. All of Nexalin’s products are non-invasive and undetectable to the human body and are intended to provide relief to those afflicted with mental health issues without adverse side effects. Nexalin utilizes bioelectronic medical technology to treat mental health issues without the need for drugs or psychotherapy. Nexalin believes the 15 milliamp medical device can penetrate structures deep in the mid-brain that are associated with mental health disorders. These deeper penetrating waveforms are believed to generate enhanced patient response without any adverse side effects. The Nexalin tACS device was approved in China by the National Medical Products Administration (NMPA) for the treatment of insomnia and depression. The tACS devise currently is distributed in the Asia Pacific region through a joint venture with Wider Come Limited, and further clinical research is ongoing. Additional information about the Company is available at: https://nexalin.com/.
FORWARD-LOOKING STATEMENTS
This press release contains statements that constitute "forward-looking statements," including with respect to the Company’s initial public offering. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's registration statement and prospectus for the offering filed with the SEC. Copies are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
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