0708 A Study To Determine Efficacy Of A Device In Anticipating Obstructive Sleep Apnea Events

Abstract

Abstract Introduction Current treatment options for obstructive sleep apnea pose multiple challenges ranging from issues with therapy adherence (i.e. PAP) to partial effectiveness (i.e. MAD) or invasiveness (i.e. implantable nerve stimulation devices). SleepMethods, Inc. designed a device that proposed to solve these issues. It consisted of two integrated mechanisms; one to anticipate the development of an obstructive event and the other to deliver therapeutic intervention to abort the process of airway collapse before it ensued. A clinical trial was conducted to test the efficacy of the system designed to anticipate obstructive sleep apnea events. Methods Ten adults (7M;3F) aged 18-80y/o (avg. 54.7y/o) with a known AHI ≥ 15/hr (avg. AHI = 42.6/hr) underwent 1 overnight PSG recording while wearing the device. Patients were required to forego their usual CPAP therapy on the night of study in efforts to expose the device to an adequate number of total obstructive events (defined as apneas and hypopneas; RERAs and snores were excluded). Standard PSG analysis was performed. Scoring rules were applied to determine whether signals were true/false positives and/or true/false negatives based on pre-clinical data showing anticipation accuracy for up to 45 seconds prior to an obstructive airway event. Results Preliminary results suggest the device functions with 96.9% sensitivity and about 67.1% PPV. Data analysis is ongoing to determine specificity, statistical significance, etc. Conclusion The device has shown promise in pre-clinical and clinical trials to accurately and consistently anticipate airway collapse; a possible breakthrough in designing more targeted therapies aimed at aborting obstructive sleep apnea events before they ensue to a clinically significant degree. Support N/A