0459 Cardiovascular Endpoints for Obstructive Sleep Apnea with Twelfth Nerve Stimulation: Measures of Sleep-Related Function

Abstract Introduction Obstructive sleep apnea (OSA) is an increasingly prevalent sleep-related breathing disorder linked to cognitive dysfunction and daytime sleepiness. Positive airway pressure (PAP) therapy, the first-line treatment for OSA, may improve function sleepiness, but responses vary. Hypoglossal nerve stimulation (HGNS) a novel effective PAP alternative, its effect on mitigating decline secondary OSA unknown. In first sham-controlled HGNS trial, we evaluated of therapy measures patient-reported outcomes (PROs) in patients with moderate-severe OSA. Methods double-blind, sham-controlled, randomized crossover already stabilized underwent four weeks active sham HGNS, each 1-week washout period. Sham was defined as lowest voltage at which sensed by patient or visualized clinician. Cognitive (Psychomotor Vigilance Test [PVT], Digit Symbol Substitution Task [DSST]) PROs (Epworth Sleepiness Scale [ESS], Snoring Visual Analog [VAS], Insomnia Severity Index [ISI], Functional Outcomes Sleep Questionnaire [FOSQ]) were assessed after 4-week period compared between therapy. Results Sixty included. On average, participants elderly (67.3±9.9 years), overweight (BMI 28.7±4.6 kg/m2) had severe prior (AHI 33.1±14.9 events/hour). Patients’ AHI decreased 23.0±15.6 events/hour (p=0.0001) 18.1±14.8 (p< 0.0001), 4.9 event/hour decrease (p=0.014). There no significant differences performance PVT DSST HGNS. All statistically moderately large (effect sizes ~0.41-0.56) improvements following Conclusion The system permits unique investigation “on/off” function. trial using all PROs, not objective cognition, significantly different (therapeutic) levels. These findings warrant additional examining relationship subjective Support (if any) American Heart Association (17SDG33670349) Medicine Foundation (176-JF-17) National Institutes Health (P01-HL094307)