Vivos’ Oral Appliance Shows 100% Improvement in Insomnia Study
Event summary
- Vivos’ Vida® appliance improved insomnia severity in all 37 study participants, with an average ISI score reduction of 65%.
- The single-site clinical study was conducted between 2022 and 2025, involving adults aged 28–77 with moderate to severe insomnia.
- Vivos projects a $36 million annual addressable market for insomnia treatment in Las Vegas alone, based on existing patient referrals.
- The Vida® appliance is currently FDA-cleared for TMJ disorders, migraine headaches, and nasal airway dilation but not yet for insomnia.
The big picture
Vivos Therapeutics is positioning itself to tap into the underserved global insomnia market, which affects 10–30% of adults. The company’s FDA-cleared oral appliance could offer a non-invasive alternative to existing pharmacologic and behavioral therapies, potentially expanding its addressable market beyond obstructive sleep apnea (OSA). With over 36,000 annual patient referrals at Sleep Centers of Nevada alone, Vivos has a significant opportunity to scale its insomnia-focused protocols.
What we're watching
- Market Expansion Potential
- Whether Vivos can sustain growth by integrating insomnia treatment into its existing sleep disorder platform.
- Regulatory Approval
- The pace at which the FDA may review and clear the Vida® appliance for insomnia treatment.
- Provider Adoption
- How quickly healthcare providers adopt the Vida® appliance for insomnia, given its non-pharmacologic approach.