Oral Appliance and Pharmacological Agents in the Treatment of Sleep Apnea: A Pilot Clinical Study

Hypothesis: Augmentation of a mandibular advancement oral appliance (OA) by pharmacotherapy (ondansetron+fluoxetine) will increase therapeutic efficacy in moderate to severe obstructive sleep apnea (OSA) patients. Methods: Fifteen subjects met inclusion criteria and were enrolled. Subjects with moderate-severe OSA were treated with a TAP3 Elite® OA plus placebo medication for two weeks, followed by a combination regimen of ondansetron (24 mg/day) and fluoxetine (10 mg/day) with continued use of the OA for four weeks. Results: Seven subjects (5 male and 2 female, BMI 39.1±6.6) completed the study. AHI OA + Medications (22.1±16.3) was lower than the AHI baseline (31.7±11.2). Sleep efficiency and oxygen desaturation indices improved. Subjective (ESS) and objective (PVT) daytime sleepiness showed improvement. Mean total airway volume at end inspiration increased by 35% with OA compared to without OA. Minimum cross sectional area (CSA) increased by 48.8% with OA compared to without OA Conclusions: Combination of pharmacotherapy and oral appliance maybe a viable option in treating patients with moderate to severe OSA.