Treatment with a lingual-less precision oral appliance significantly reduced the apnea-hypopnea index from 21.0 to 13.6 events/hour (p<0.001) and hypoxic burden by 41.6% (p=0.00036) in OSA patients.
Cohort (n=21)
Does a lingual-less design oral appliance reduce apnea-hypopnea index and hypoxic burden in patients with obstructive sleep apnea?
Treatment with a novel lingual-less oral appliance significantly reduced both the apnea-hypopnea index and sleep apnea-specific hypoxic burden in patients with obstructive sleep apnea.
Effect estimate: mean percent change -29.51%
Absolute Event Rate: 13.6% vs 21%
p-value: p=<0.001
Abstract Introduction Oral appliance therapy (OAT) is commonly used to treat obstructive sleep apnea (OSA), yet real-world outcomes are frequently summarized using apnea-hypopnea index (AHI) alone. Sleep apnea-specific hypoxic burden (HB), a metric that is predictive of OSA-associated risk, may provide complementary information regarding physiologic impact. We evaluated patient-level changes in AHI and HB using paired baseline and post-treatment home sleep apnea tests following treatment with a novel, lingual-less precision oral appliance. Methods This retrospective chart review included patients treated with an EVO Guided oral appliance (ProSomnus Sleep Technologies, Pleasanton, CA), a new precision oral appliance with a lingual-less design. Patients with both a baseline and post-OAT Type III home sleep apnea test (HSAT). were included in the analysis. HSATs were interpreted by qualified clinicians (sleep physician and/or dentist, per local practice). For patients with multiple baseline and/or post study nights, values were averaged to generate one baseline and one post value per patient. Outcomes included AHI and HB. Analyses were summarized for all patients and by baseline severity (moderate, severe). Paired t-tests were performed for the full cohort. Results Twenty-one patients had paired baseline and post-OAT HSATs. For all patients, the mean AHI decreased from 21.0±10.1 to 13.6±6.7 events/hour, with a mean percent change of −29.51% (SD 0.4; p 0.001). Mean HB decreased from 30.6±18.2 to 16.5±12.7 %min/hour, with a mean percent change of −41.62% (SD 0.3; p=0.00036). In patients with moderate OSA (n=9), the mean percent change was −36.72% for AHI and −52.39% for HB. In patients with severe OSA (n=6), the mean percent change was −56.93% for AHI (3%) and −56.46% for HB. Conclusion In this real-world retrospective cohort, OAT was associated with significant reductions in both AHI and sleep apnea-specific hypoxic burden, with larger average improvements observed in patients with severe OSA. The reductions in AHI and HB are of particular interest because they reflect only the interim assessment of the device, not its true efficacy. Additional patient follow-up is needed to optimize therapeutic efficacy. Support (if any)
LaFollette et al. (Fri,) conducted a cohort in Obstructive sleep apnea (OSA) (n=21). EVO Guided oral appliance vs. Baseline was evaluated on Apnea-hypopnea index (AHI) (mean percent change -29.51%, p=<0.001). Treatment with a lingual-less precision oral appliance significantly reduced the apnea-hypopnea index from 21.0 to 13.6 events/hour (p<0.001) and hypoxic burden by 41.6% (p=0.00036) in OSA patients.