FDA Clears Neurovalens’ Modius Sleep Device for Insomnia

Jason McKeown

According to an announcement from Neurovalens, the FDA has granted 510(k) clearance for its Modius Sleep device as a new treatment for patients with chronic insomnia. The company is now planning to enter discussions with insurance providers to achieve reimbursement status so patients can access the treatment through their medical insurance.¹

"Having the Modius Sleep technology as a certified medical device for the treatment of chronic insomnia is a landmark step for the company as we focus on future growth in the US market," Jason McKeown, chief executive officer at Neurovalens, said in a statement.¹ "Most other products on the market measure symptoms of insomnia, but Modius Sleep is a non-invasive device that actually treats the underlying issue, improving the lives of our patients."

Modius Sleep is a transdermal neurostimulation device with a battery-powered headset designed to transcutaneously deliver low-level electrical current to a patient’s head to treat insomnia. The device delivers neurostimulation through 2 self-adhesive electrode pads that are placed on the subject’s skin overlying each mastoid process behind the ear.²

In its announcement, Neurovalens claimed that it has approvals pending for the sleep device in other conditions of anxiety and obesity. The decision to grant clearance for the device was based on a robust phase 3 clinical trial carried out in the UK and Ireland by Ulster University and a pivotal trial in Hong Kong by PolyU University. As it enters the market, the company will continue to run clinical trials on the effectiveness of the drug-free technology in treating other conditions.

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In 2019, a published pilot study demonstrated the effectiveness of noninvasive electrical vestibular stimulation using Modius Sleep. The trial featured 20 adults with mild to moderate insomnia who were given daily sessions of 30 minutes for a period of 14 days. These sessions were delivered approximately 1-hour prior to sleep onset, with changes in insomnia severity index (ISI) score as the primary outcome. After 14 days, investigators observed a statistically significant change in mean ISI score, going from 15.7 to 8.15 (P <.00001).³

McKeown added, "We believe that the low risk, non-invasive therapeutic intervention offered by Neurovalens technology will be truly transformative for a range of serious medical conditions and, having carried out extensive clinical trials in the US and Northern Ireland, we’re really excited to be moving to this next stage."¹

Modius Sleep is not worn in bed, but rather in the evening before bed, ideally as a patient is starting to wind down before their sleep. Patients who use the device will determine the level of neurostimulation once they begin to experience the gentle swaying indicating modulation of the vestibular nerve. After 30 minutes of neuromodulation, the device will turn off. The small electrical current delivered onto the skin through electrode pads serves as a neurosignaling waveform which modulates cranial nerves that influence the balance between the parasympathetic and sympathetic nervous systems.²

REFERENCES
1. Neurovalens receives FDA clearance for medical device to treat insomnia. News release. Neurovalens. October 31, 2023. Accessed November 6, 2023. https://neurovalens.com/blogs/news/neurovalens-receives-fda-clearance-for-medical-device-to-treat-insomnia
2. Cheung T, Lam JYT, Fong KH, et al. Evaluating the efficacy of electrical vestibular stimulation (VeNS) on insomnia adults: study protocol of a double-blinded, randomized, sham-controlled trial. Int J Environ Res Public Health. 2023;20(4):3577. doi:10.3390/ijerph20043577
3. Mckeown J, Goothy SSK. P050 modulation of sleep using electrical vestibular nerve stimulation prior to sleep onset. BMJ Open Respiratory Research. 2019;6. doi:10.1136/bmjresp-2019-bssconf.50