Study: Vivos Therapeutics Sleep Apnea Device Helps Improve Pediatric ADHD

Vivos Therapeutics Inc. has released previously unpublished clinical data indicating treatment with its U.S. Food and Drug Administration (FDA)-cleared Daytime-Nighttime Appliance (DNA) can relieve Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children.

Vivos’ DNA appliance is marketed as the only FDA-cleared non-surgical, non-pharmaceutical treatment for moderate to severe pediatric obstructive sleep apnea (OSA) in children ages 6-17, and is increasingly seen as a viable alternative to adenotonsillectomy surgery for OSA. The DNA appliance is part of Vivos’ Complete Airway Repositioning and Expansion (C.A.R.E.) device lineup authorized by the FDA to treat OSA in both children and adults.

Diagnosed ADHD rates in the United States have roughly quadrupled since the 1980s—from an estimated 2% to 3% of school-aged children (circa 1985) to just over 11% by 2022, according to the Centers for Disease Control and Prevention (CDC). The prevalence of OSA in a preschool pediatric population similarly increased from 3% to 9% before 2014, to 13% to 20% by 2022. Children with OSA are often misdiagnosed as having ADHD due to the bidirectional nature and overlap of these two conditions in the pediatric population.

Multiple studies show a strong link between pediatric OSA and the incidence of ADHD symptoms, with attention deficits reported in up to 95% of pediatric OSA patients. Other studies show moderate to severe pediatric OSA patients are most likely to exhibit ADHD symptoms. By 2022, an estimated 7.1 million U.S. children and adolescents (about one in nine) had been diagnosed with (ADHD), according to the CDC. Multiple studies have shown that treatment for OSA can dramatically reduce or eliminate ADHD symptoms.

“We are seeing a large and untapped market to effectively address ADHD symptoms by treating a child’s OSA using Vivos’ non-surgical and non-pharmaceutical approach. Parents are wary of putting their children through painful surgeries or giving them drugs. Vivos is the first to offer a safe and effective FDA-cleared alternative. And although our Vivos DNA treatment is not yet FDA-cleared to treat ADHD per se, we believe this data strongly suggests that by successfully treating a child’s OSA it is possible to reduce or eliminate ADHD symptoms and behaviors,” Vivos Therapeutics Chairman/CEO Kirk Huntsman stated.

In this current dataset released by Vivos, children treated with the Vivos DNA appliance reported a 50% decrease in the validated Pediatric Sleep Questionnaire (PSQ), which measures snoring, sleep apnea, and restless legs (p<0.00001). Moreover, these children showed a 58% decrease in symptoms of sleep disordered breathing and ADHD symptoms such as disruptive behavior and hyperactivity.

Forty-eight (48) of the original 55 patients completed the clinical trial. There were 28 males and 20 females, with an average age of 10.6 years. As expected from previous studies, 100% of patients increased both their transpalatal width (+13.6%) and their airway volume (+40%), while the severity of their OSA decreased by 51.4% (as measured by their Apnea-Hypopnea Index (AHI) scores). All improvements were statistically significant. The majority of this improvement was shown to occur in the first six months of treatment.

Vivos Therapeutics Inc. is developing and commercializing 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.

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 in both children and adults. 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, and the temporary positive effects of painful surgical interventions such as adenotonsillectomies in children tend to diminish over time.

Founded in 2016 and based in Littleton, Colo., Vivos is striving to address the needs of OSA patients through technology, education, and acquisitions of, or commercial collaborations with, sleep healthcare providers. 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.