Vivos Therapeutics Inc, a medical technology company developing treatments for patients with obstructive sleep apnea (OSA) and snoring, announced that its flagship daytime-nighttime appliance (DNA) will be tested in a clinical trial at Stanford Medicine.
The protocol has been finalized, and participant enrollment will begin in early 2024. Study participants with moderate to severe OSA will be randomly assigned to either treatment with Vivos’ DNA appliance or CPAP, the current industry standard for OSA treatment. Sleep studies will be performed prior to and following a course of treatment using in-lab polysomnography to assess changes in the patients’ apnea-hypopnea index (AHI).
The DNA appliance received 510(k) clearance by the US Food and Drug Administration for the treatment of mild-to-moderate OSA in adults in December 2022.
“In a retrospective review of 220 patients, we have seen that Vivos’ oral appliance therapy decreases the apnea-hypopnea index while increasing airway volume. The median reduction in AHI was 49% in this cohort and a quarter of patients resolved their OSA completely. These end results were measured after a 12-18 month course of therapy without the appliance in the mouth—meaning the effects persisted while not using treatment—something not seen with CPAP,” says Cecilia Wu, MD, co-chair of the clinical advisory board at Vivos Therapeutics, in a release. “While Vivos believes in these results, it is important to apply the highest standards in medical research in the form of a prospective randomized controlled trial. This will truly test Vivos’ treatment to the same standard as all other modalities.”
R. Kirk Huntsman, chairman and CEO of the company, adds in the release, “We are extremely excited to be starting this trial at Stanford Medicine, which has been in the works for some time. I am confident that our technology will bear the scrutiny of a well-designed, prospective clinical trial. There is no better place for our technology to undergo rigorous scientific testing than at a respected institution like Stanford. Our treatment is comfortable, safe. and non-invasive, and we believe that at the end of this study, the conclusion will be that Vivos should become an essential part of every OSA care plan.”
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