Efficacy of a novel invisible mandibular advancement device in patients with mild to moderate obstructive sleep apnea: a preliminary study

Objectives To investigate the efficacy and working mechanism of a novel invisible mandibular advancement devices (iMAD) on respiratory parameters and upper airway in obstructive sleep apnea (OSA) patients. Materials and Methods Patients with mild to moderate OSA were recruited and each OSA patient underwent two home sleep apnea test (HSAT), and two cone beam computed tomography (CBCT) scans in supine position: one at baseline and one after 3 months with the iMAD in situ . The primary outcome variables were the obstructive apnea index (OAI), the minimal cross-sectional area (CSAmin) of the upper airway, and airway resistance derived from computational fluid dynamics (CFD). Results A total of 48 patients were recruited, and 27 patients with a mean (± SD) age of 42.44 (±7.64) years and a mean OAI of 15.59 (±6.86) /h completed the study. HSAT results showed that there was significant decrease in the OAI with iMAD in situ (p < 0.001). Nearly half of the patients (48.1%) met the responder criterion (≥ 50% reduction in OAI). CBCT showed that there was significant increase in the CSAmin of the upper airway with iMAD in situ (p < 0.001). CFD analysis showed that the maximum velocity of the mid-sagittal plane was significantly reduced with iMAD in situ (p < 0.05). Conclusions Within the limitations of this study, we conclude that iMAD could improve the respiratory parameters, increase upper airway dimensions, and reduce airflow velocity in mild to moderate OSA patients. Clinical Relevance: iMAD may offer an esthetic, comfortable alternative to conventional MAD for mild to moderate OSA. Trial registration: chictr.org.cn (ChiCTR2400092896)