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Key takeaways:
- In a study of 37 adult patients, the Vida oral appliance reduced Insomnia Severity Index scores by an average of 65%, with 100% of participants improving by at least one classification level.
- “I believe the Vida helps modulate autonomic nervous system balance during sleep, and the consistency of improvement across all 37 patients in the study suggests real potential for broader clinical adoption as awareness and supporting data continue to emerge.”
- Insomnia frequently co-occurs with obstructive sleep apnea.
Unpublished clinical data shows that treatment with Vivos Therapeutics Inc’s Vida oral appliance led to a statistically significant improvement in insomnia severity in 100% of study participants, according to Vivos.
In a single-site clinical study conducted between 2022 and 2025, 37 adult patients (30 females, 7 males) aged 28 to 77 years with longstanding clinically moderate to severe insomnia were treated with the Vida appliance. Patients wore the device nightly for an average of 3.7 months. Insomnia severity was defined by the validated Insomnia Severity Index (ISI).
Patients experienced an average ISI score reduction of approximately 65%. Every participant improved by at least one ISI classification level, and all patients were ultimately classified as having either no clinically significant insomnia or subthreshold insomnia.
“The results of this clinical study are consistent with what we’ve seen with thousands of COMISA patients—symptomatic relief comes fast, with no material safety issues, and appears to have lasting effects—all at a reasonable cost,” says R. Kirk Huntsman, chairman and CEO at Vivos, in a release. “These results suggest that the Vida appliance could open an important new treatment modality and revenue source as we address one of the most prevalent and costly sleep disorders worldwide.”
The Vida appliance, formerly the Pod oral appliance (developed by Advanced Facialdontics and acquired by Vivos in early 2023), is currently cleared by the US Food and Drug Administration (FDA) as a Class II device for the amelioration of clenching and bruxing associated with TMD and is to be used to aid in the relief of symptoms of TMD/TMJ. While the clinical data relating to insomnia symptom improvement have not been reviewed or cleared by the FDA, Vivos states it has been advised that the present clinical data are sufficient to proceed without such regulatory clearance.
“For patients and providers who are looking for effective, nonpharmacologic options for chronic insomnia, the clinical response we observed with nightly use of the Vida appliance is encouraging,” says Scott Simonetti, DDS, the dentist who conducted the study and the inventor of the Unilateral BiteBlock Technology used in the Vida oral appliance, in a release. “I believe the Vida helps modulate autonomic nervous system balance during sleep, and the consistency of improvement across all 37 patients in the study suggests real potential for broader clinical adoption as awareness and supporting data continue to emerge.”
Insomnia frequently co-occurs with obstructive sleep apnea (OSA). In patients with moderate to severe OSA, co-morbid insomnia (COMISA) is present in up to 60% or more of patients. Vivos estimates that it may realize approximately $2,000 per insomnia patient from both testing and treatment. While related home EEG testing may receive insurance reimbursement, the Vida appliance treatment is not typically reimbursed by most insurance carriers and would thus be paid for out of pocket.
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