New Study Finds Vivos Oral Appliance Reduces Insomnia Severity in 100% of Participants

Insomnia is a common sleep disorder that affects millions of people worldwide. It can be challenging to treat, and often requires a combination of lifestyle changes and medical interventions. However, a recent study has shown that the Vida oral appliance, developed by Vivos Therapeutics Inc, may be a effective treatment option for insomnia. ## The Study The study, which was conducted between 2022 and 2025, involved 37 adult patients with clinically moderate to severe insomnia. The patients wore the Vida appliance nightly for an average of 3.7 months, and their insomnia severity was measured using the validated Insomnia Severity Index (ISI). The results showed that all 37 participants experienced symptom improvement, with an average reduction in ISI scores of 65%. ## The Vida Appliance The Vida appliance is a Class II device that is currently cleared by the US Food and Drug Administration (FDA) for the treatment of temporomandibular joint (TMD) disorders. However, the clinical data relating to insomnia symptom improvement have not been reviewed or cleared by the FDA. Vivos Therapeutics Inc states that it has been advised that the present clinical data are sufficient to proceed without such regulatory clearance. ## Potential Benefits The study's findings suggest that the Vida appliance may be a effective treatment option for insomnia. The appliance is non-pharmacologic, meaning that it does not involve the use of medication, and it may be a more cost-effective option for patients who are looking for an alternative to traditional treatments. Additionally, the study's results suggest that the Vida appliance may be a useful treatment option for patients with co-morbid insomnia and obstructive sleep apnea (OSA). ## Future Directions While the study's findings are promising, further research is needed to fully understand the benefits and limitations of the Vida appliance as a treatment for insomnia. Vivos Therapeutics Inc estimates that it may realize approximately $2,000 per insomnia patient from both testing and treatment, although the Vida appliance treatment is not typically reimbursed by most insurance carriers and would thus be paid for out of pocket. As awareness and supporting data continue to emerge, it is likely that the Vida appliance will become a more widely accepted treatment option for insomnia. The study's results are consistent with what Vivos Therapeutics Inc has seen with thousands of patients who have used the COMISA treatment, which suggests that the Vida appliance could open an important new treatment modality and revenue source as it addresses one of the most prevalent and costly sleep disorders worldwide.