Nexalin Technology Announces Positive Results from Clinical Study of its Gen-2 tACS Device for Treating Adult Patients with Chronic Insomnia

• 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).