Abstract

Abstract Introduction Current treatment options for obstructive sleep apnea (OSA) include positive airway pressure, oral appliances, and upper airway surgery. The Day and Night Appliance (DNA) is a component of a dentist-guided system (Complete Airway Repositioning and Expansion [CARE], Vivos Therapeutics) that leads to gradual increases in upper airway volume. This study examines the effects of DNA treatment on OSA in patients before and after use of the device; we also examined how DNA treatment was impacted by concurrent myofunctional and CPAP therapy. Methods Data from a prospectively-collected clinical database (Vivos Airway Intelligence Service [AIS]) were reviewed, and 94 adult OSA patients who met DNA use criteria and had pre- and post-treatment sleep studies without the device in place were included. We compared the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) pre- and post-treatment using a paired t-test and fit linear regression models with change in AHI and ODI as dependent variables. Results Mean patient age was 47.8±14.7 years and 44.7% were men. Pre- and post-treatment sleep studies were conducted 15.2±7.0 months apart. 24.5% of patients were treated with DNA and myofunctional therapy (14.1% exclusively myofunctional, 10.4% myofunctional plus another treatment, e.g., tonsillectomy, frenectomy). 17.0% of patients were treated with CPAP (12.8% exclusively CPAP, 4.2% CPAP plus another treatment). For both pre-treatment and post-treatment, mean AHIs were 22.3±19.4 and 12.7±11.2 respectively (p< 0.0001) and mean ODIs were 11.6±13.7 and 7.8±9.1 respectively (p< 0.0001). Excluding patients who had undergone myofunctional therapy and another treatment modality and adjusting for patient age, BMI, and gender, we found myofunctional therapy was associated with a -10.4 change in AHI (p=0.038). However, myofunctional therapy was not associated with a significant change in ODI (p=0.905). Concurrent CPAP use did not have a significant association with change in either AHI (p=0.47) or ODI (p=0.61). Conclusion This study shows that DNA use significantly improved post-treatment OSA severity, and that concurrent myofunctional but not CPAP therapy may result in further OSA improvement. An oral appliance system that provides palatal expansion with consequent improvement in OSA severity but does not require permanent nightly use has advantages over conventional oral appliances; however, further investigation is warranted. Support (if any)

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