Vivos Therapeutics Announces Study Results in Pediatric OSA Treatment

Clinical trial results show Vivos Therapeutics Inc.’s Vivos DNA (Daytime-Nighttime Appliance) is an effective treatment for children suffering from obstructive sleep apnea (OSA)

Results from a multicenter clinical trial, published in the European Journal of Pediatrics, represent a significant milestone in the fight against one of the most underdiagnosed and undertreated pediatric health conditions. The DNA appliance is part of Vivos’ Complete Airway Repositioning and Expansion (C.A.R.E.) device lineup.

According to recent published research estimates, up to 20.4% of U.S. children—as many as 10 million— are living with pediatric OSA, a condition linked to ADHD behaviors, allergies, bedwetting, reduced IQ, aggressive behavior, and academic struggles. Alarmingly, up to 90% of these children remain undiagnosed. For those who are diagnosed, the current standard of care is adenotonsillectomy (AT) surgery, which is invasive, painful, and only effective for 20% to 40% of pediatric patients—with symptoms recurring in up to 25% of cases.

This new trial revealed significant outcomes in pediatric OSA patients who were treated with the DNA appliance:

• 77% of participants experienced at least a 50% reduction in OSA severity.
• Among children with severe OSA, 93% reached a 50% reduction in OSA severity.
• 17% of patients in the study achieved complete resolution of their OSA.
• Airway volume increased by an average of 67.8%, a primary endpoint of the study.
• Pediatric Sleep Questionnaire (PSQ) symptom scores decreased by 31%, a statistically significant improvement.

“We believe this data signals a new era in pediatric OSA treatment,” Vivo Therapeutics Chairman/CEO Kirk Huntsman said. “For over a century, surgery has been the go-to treatment for children with OSA. With these results, parents and providers now have strong evidence supporting our DNA appliance as a safe, non-surgical alternative. No child should face invasive surgery without first considering our FDA cleared appliance available through Vivos-trained healthcare providers.”

This latest study adds to a growing body of evidence supporting Vivos’ oral appliance therapies for pediatric patients. Since publication, certain study authors have been invited to present the findings of this and other Vivos research to medical and dental audiences worldwide. Recently, lead author Clete A. Kushida, M.D., Ph.D., director of the Stanford Center for Human Sleep Research at Stanford University, presented the results of a separate new study highlighting the safety and efficacy of Vivos C.A.R.E device technology at the World Sleep Congress 2025 in Singapore. Dr. Kushida chairs Vivos’ Medical Advisory Board and has co-authored a number of papers on Vivos device technology.

In addition to the DNA appliance and other C.A.R.E devices, Vivos also offers Vivos Guides—specialized devices designed for guided jaw growth and development in children. These appliances are intended to support proper craniofacial growth at an early age, which may help children avoid the need for obstructive sleep apnea treatment later in life. Clinical data also shows that Vivos Guides can help alleviate symptoms associated with underdeveloped jaw growth, including ADHD behaviors and nocturnal enuresis (bedwetting).

• In one study, Vivos Guides virtually eliminated bedwetting in children, with 50% seeing results within two weeks and 97.4% resolving within 60 days.
• Another study showed that 61% of children with OSA reported their ADHD symptoms were completely resolved or rarely occurred after just seven months of treatment.
• A third study found that 90% of children had their OSA symptoms completely resolved after a similar treatment period.

Healthcare providers trained in the Vivos Method also integrate U.S. Food and Drug Administration (FDA) 510(k)-cleared adjunctive therapies, including laser treatments to address swollen tonsils, which may provide near-term relief alongside long-term airway development.

OSA affects more than 1 billion people worldwide, yet 90% remain undiagnosed and unaware of their condition. This chronic disorder is not just a sleep issue—it’s closely linked to many serious chronic health conditions. While the medical community has made strides in treating sleep disorders, breathing and sleep health remain areas that are still not fully understood. As a result, legacy OSA treatments like CPAP are often mechanistic and fail to address the root causes of OSA.

Vivos Therapeutics Inc. develops and commercializes diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as OSA and snoring in adults. Vivos’ devices have been cleared by the FDA for adult patients diagnosed with all severity levels of OSA and moderate-to-severe OSA in children ages 6 to 17. Vivos’ Complete Airway Repositioning and Expansion (CARE) devices are touted as the only FDA 510(k)-cleared technology for treating severe OSA in adults and the first to receive clearance for treating moderate to severe OSA in children.

Founded in 2016 and based in Littleton, Colo., Vivos calls the use of its appliances and protocols to treat OSA The Vivos Method, which offers a proprietary, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical.