A multicenter pediatric trial of Vivos Therapeutics’ DNA (Daytime-Nighttime Appliance) reported that 77% of participants achieved at least a 50% reduction in OSA severity, including 93% of children with severe OSA, with 17% reaching complete resolution. Airway volume increased by a mean of 67.8% (primary endpoint), and Pediatric Sleep Questionnaire scores fell by 31%. The peer-reviewed results were published in the European Journal of Pediatrics.
The core development is Vivos’ first multicenter, peer-reviewed publication linking its C.A.R.E. oral appliance platform to clinically meaningful improvements in pediatric OSA. The company positions the DNA device as a non-surgical alternative to adenotonsillectomy and CPAP, noting prior FDA 510(k) clearances for moderate-to-severe OSA in children 6–17 and for all severity levels in adults. The trial establishes a public evidence marker for a category that has been viewed as promising but underpowered by rigorous clinical data, particularly in younger patients.
Strategically, the timing is deliberate. Payers and guideline bodies have pressed for higher-grade evidence before broad coverage of dental and craniofacial interventions for OSA, and ENT and sleep specialists remain cautious about appliances that hinge on airway remodeling during growth. Publishing in a pediatric journal gives Vivos a foothold in a community that still defaults to surgery or CPAP for moderate-to-severe disease. The choice of airway volume as the primary endpoint underscores the company’s mechanistic thesis but also highlights the ongoing tension: radiographic expansion is a surrogate, and many stakeholders will want polysomnographic anchors such as absolute and relative OAHI changes, arousal indices, and sustained remission post-treatment. The release does not disclose sample size, duration, control status, or adverse event rates, which will shape how quickly clinicians and payers recalibrate.
For sites, a validated appliance pathway could reconfigure referral flows, bringing pediatric dentists, orthodontists, sleep clinics, and ENTs into tighter operational alignment. Protocols will need standardized imaging, PSG, and symptom measures, along with adherence tracking and growth-phase safety monitoring. Sponsors and CROs should note the feasibility signal for multicenter enrollment and the potential to employ hybrid designs that mix objective imaging with PSG endpoints. Regulators may view the publication as supportive of prior clearances while still expecting confirmatory, comparator-based data for label expansions or stronger claims. Payers will zero in on durability, retreatment rates, and resource utilization relative to adenotonsillectomy and CPAP. For patients and families, a non-surgical option with published outcomes is material; however, clinical decision-making will remain contingent on the severity, craniofacial phenotype, and comorbidities.
The next test is comprehensiveness. A randomized, controlled trial against adenotonsillectomy or CPAP—reporting absolute OAHI changes, quality-of-life gains, and 12–24 month durability off therapy—would move this from promising to practice-changing in the eyes of guideline committees. Safety characterization needs equal rigor: dental arch effects, temporomandibular symptoms, speech and feeding impacts, and growth trajectory interactions. Investigators should also stratify by age, BMI, nasal obstruction, and craniofacial morphology to define responders and avoid indiscriminate use. On the market access front, watch for payer policy updates, coding pathways that bridge dental and medical benefits, and whether major pediatric centers integrate appliance protocols into multidisciplinary clinics. The broader signal is that pediatric OSA is opening to non-surgical structural therapies, but adoption will hinge on head-to-head data, durability, and operational simplicity at scale.
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.
