FDA clears Neurovalens' neurostim headset to treat chronic insomnia

People suffering from chronic insomnia now have a new, drug-free option to treat the condition in the U.S.

The FDA doled out a clearance to Neurovalens’ Modius Sleep device, which relies on neuromodulation technology to target the neurological processes that cause insomnia. With the regulatory nod, the Northern Ireland-based company will now be able to focus on growing its stateside presence, CEO Jason McKeown, Ph.D., said in a company announcement.

“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,” McKeown continued. “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 U.S. and Northern Ireland, we’re really excited to be moving to this next stage.”

The Modius Sleep device is a headset that delivers small electrical pulses through an electrode placed behind the ear, with an aim of stimulating the areas of the brain’s hypothalamus associated with the sleep-wake cycle and the circadian rhythm.

According to Neurovalens, users should wear the headset for a 30-minute session before bed, during which they’re free to watch TV, read or do other activities as they wind down for the night.

The device’s neurostimulation is meant to improve both the quality and duration of sleep. In a pilot study (PDF) of the technology in 2020, 20 adults were tasked with using the neurostimulation headset every night before bed for two weeks. By the end of the study period, they reported significant decreases in their Insomnia Severity Index (ISI) scores, as well as an improvement in how well-rested they felt throughout the day.

Specifically, the participants kicked off the study with an average baseline ISI score of 15.7, indicating “moderate insomnia” on the 28-point scale, and after two weeks their average score had dropped to 8.15, well below the threshold for a clinical diagnosis of insomnia. Meanwhile, when asked to rate their restfulness on a scale of zero to four, the participants’ scores improved from an average of 1.6 before the study started to 2.67 after undergoing the two weeks of regular Modius Sleep treatment.

Neurovalens’ FDA submission was supported by the results of a “robust” pivotal clinical trial conducted in the U.K., Ireland and Hong Kong, the results of which haven’t yet been published.

Next up on the company’s agenda is a plan to work with insurance providers to secure reimbursement for U.S. users of the Modius sleep device.

In the meantime, Neurovalens is also in the process of adapting its neurostimulation technology to a variety of other indications, including Type 2 diabetes, obesity, anxiety and post-traumatic stress disorder, the last of which is on deck to be studied in a now-recruiting clinical trial.