Modius Sleep, a non-invasive neurostimulation device designed for home use, is now available to treat chronic insomnia in adults aged 22 and older.
Approved by the FDA in October 2023, this prescription-only, portable device stimulates the vestibular nerve through battery-operated electrical signals. These signals are delivered to the skin behind the ears, over the mastoid bone, via two self-adhesive electrode pads, targeting the hypothalamus through a specific neural pathway.
According to the manufacturer, the FDA clearance was based on a multi-site, pivotal, randomized, double-blind, sham-controlled trial (ClinicalTrial.gov Identifier: NCT04452981), which evaluated the safety and effectiveness of Modius Sleep for treating chronic insomnia.
In the study, 149 participants with Insomnia Severity Index (ISI) scores of 15 or higher were randomly assigned to use either the Modius Sleep device or a sham device for 30 minutes each evening before bedtime over four weeks. The primary efficacy measure was the change in ISI scores from baseline to the fourth week, while safety was assessed through the rate of adverse events in both groups.
Results showed a significant reduction in ISI scores among Modius Sleep users, with a 24.5% (4.85) decrease in the intention-to-treat (ITT) cohort and a 29.4% (5.80) decrease in the per protocol (PP) cohort. In comparison, the sham group showed reductions of 17.1% (3.14) in the ITT and 19.2% (3.52) in the PP cohorts. Additionally, improvements in energy and fatigue levels (based on SF-36 scores) were higher in the Modius Sleep group compared to the sham group within the ITT cohort (P = .006).
As reported by empr, adverse events occurred in 12% (9/75) of the Modius Sleep group and 8% (6/74) of the sham group. The most frequently reported side effects with Modius Sleep were headaches, nystagmus, low mood, and mild tinnitus, with no serious device-related events.
“Our goal was to create a non-surgical solution for people with chronic insomnia,” said Dr. Jason McKeown, CEO of Neurovalens. “By non-invasively interacting with the brain’s natural sleep cycles, Modius Sleep helps users fall asleep more quickly and stay asleep longer.”
Patients interested in Modius Sleep can complete a qualification questionnaire on the Neurovalens website. Once approved, they will be connected with a physician via the company’s online platform. The device is currently available for $1,185.