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Vivos Therapeutics to Begin Clinical Trial at Stanford Medicine
Randomized controlled clinical trial using Vivos’ DNA Oral Appliance Therapy to study the DNA’s impact on OSA versus CPAP LITTLETON, Colo., Oct. 11, 2023
About this update from Vivos Therapeutics, Inc.
[{"type":"text","content":"Randomized controlled clinical trial using Vivos’ DNA Oral Appliance Therapy to study the DNA’s impact on OSA versus CPAP\nLITTLETON, Colo., Oct. 11, 2023 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company\") (NASDAQ: VVOS), a medical technology company focused on developing innovative treatments for patients suffering from mild-to-moderate obstructive sleep apnea (OSA) and snoring in adults, 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 (continuous positive airway pressure), 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 recently received 510(k) clearance by the FDA for the treatment of mild-to-moderate OSA in adults and represents an entirely novel modality of treatment for a disease that is estimated to afflict 1 in 4 adults in the United States. “In a retrospective review of 220 patients1, we have seen that Vivos’ oral appliance therapy decreases the apnea-hypopnea index (AHI) 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. “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.” “We are extremely excited to be starting this trial at Stanford Medicine, which has been in the works for some time” added R. Kirk Huntsman, Chairman and CEO of Vivos. “I am confident that our technology will bear the scrutiny of a well-designed, prospective clinical trial. There is no better place to for our tec...