0440 Real World Evidence of Non-Invasive Vestibular Nerve Stimulation for Insomnia

Abstract Introduction Modius Sleep is an FDA-cleared, noninvasive vestibular nerve stimulation device prescribed as a nonpharmacologic option for adults with insomnia. Real-world data are limited on prescribing patterns, integration into routine care, and patient progression through initiation, activation, and continuation, particularly among individuals with complex comorbidities. This post-market clinical follow-up quantifies organic adoption, comorbidity burden, implementation metrics across the fulfillment and retention pathway, and early descriptive Insomnia Severity Index outcomes. Exploratory analyses will examine related care behaviors, including PAP use and sleep-medication patterns, as additional data accrue. Methods Interim data were analyzed from a prospective, multicenter observational follow-up reviewing prescriptions recorded between March 12 and December 1, 2025. Demographics, comorbidities, and baseline characteristics were captured at prescription. Order status documented the implementation pathway (prescription, device shipped, retained). ISI scores were collected at baseline and, when available, at 4 and 8 weeks. Change in ISI was analyzed using paired t-tests (available-case analysis) and responders were defined as ≥6-point improvement from baseline. Subjective surveys assessed self-reported usage frequency, summarized by unique users. Results Data from 135 prescriptions (mean age 58.9 ± 13.4 years; 60% female) from 32 prescribers were collected. Comorbidity data (n = 95) showed 23% with ≥3 conditions; OSA, hypertension, anxiety, and depression were most common. Eighty-four devices were shipped (49 retained, 35 returned); 51 prescriptions remained incomplete. Among retained patients, 31 individuals reported device use; 55% of respondents reported daily use and 37% reported use ≥3 days/week. Baseline ISI for the full cohort (n=135) was 20.9 ± 5.3. In paired 4-week completers (n=26), ISI decreased from 20.7 ± 4.8 to 18.3 ± 4.2 (−2.4; p=0.012; 27% responders). In 8-week completers (n=18), ISI improved from 21.5 ± 5.7 to 15.4 ± 6.1 (−6.1; p< 0.0001; 50% responders). No serious device-related adverse events were reported. Conclusion This data provides descriptive real-world insight into clinician adoption of vestibular nerve stimulation for insomnia, patient complexity, and progression through fulfillment and retention. Implementation patterns and initial ISI improvements help inform priorities for future evaluation, including health-economic impact, reimbursement considerations, and controlled clinical studies to further define the role of vestibular nerve stimulation as a nonpharmacologic treatment option for insomnia. Support (if any)