A recent multi-center clinical trial published in the European Journal of Pediatrics demonstrated the safety and efficacy of Vivos Therapeutics’ Daytime-Nighttime Appliance (DNA) for treating obstructive sleep apnea (OSA) in children. The study showed a 79% improvement rate in pediatric OSA symptoms, with 93% of children with severe OSA experiencing a 50% or greater reduction in symptoms. This non-surgical approach offers a potential alternative to adenotonsillectomy.
This study is particularly important because it addresses a significant unmet need in pediatric healthcare. Millions of children suffer from undiagnosed and untreated OSA, which is linked to numerous developmental and behavioral problems. While adenotonsillectomy is a common treatment, it carries risks and a high relapse rate. The Vivos DNA device offers a less invasive, potentially more permanent solution, aligning with recent concerns about overtreatment in pediatric healthcare.
The clinical trial, involving 47 children, utilized established metrics like the Pediatric Sleep Questionnaire, apnea-hypopnea index, and intermolar width to measure treatment efficacy. The study reported no safety concerns, and researchers anticipate lasting effects beyond the 24-month study period. This contrasts with existing treatments like CPAP, adenotonsillectomy, and rapid maxillary expansion, which face limitations in adherence, complications, and continuous use.
This positive data further validates the FDA’s 510(k) clearance of the DNA device for treating moderate to severe OSA in children. It could lead to wider adoption of this non-surgical option, potentially reducing the number of children undergoing adenotonsillectomies. This could significantly impact the pediatric sleep disorder treatment landscape, offering a safer and potentially more effective long-term solution.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
