Cardiovascular endpoints for obstructive sleep apnea with twelfth cranial nerve stimulation (CARDIOSA-12): Rationale and methods.

Abstract

To determine the effect of therapeutic levels of hypoglossal nerve stimulation therapy (HGNS), compared to subtherapeutic levels of HGNS, on 24-hour ambulatory blood pressure, sympathetic activity, and vascular function. Double-blind, sham-controlled, randomized crossover trial of 10-week duration at a university medical center METHODS: The target enrollment is 60 randomly assigned subjects. Interventions are active versus sham (subtherapeutic) HGNS therapy. The primary outcome is 24-hour ambulatory systolic blood pressure. Secondary outcomes include 24-hour ambulatory diastolic blood pressure, nocturnal systolic and diastolic pressure, muscle sympathetic nerve activity, pre-ejection period, flow-mediated dilation, and pulse wave velocity. The Cardiovascular Endpoints for Obstructive Sleep Apnea With Twelfth Cranial Nerve Stimulation study is designed to examine obstructive sleep apnea and test the effects of HGNS on the cardiovascular system through a sham-controlled trial in patients with moderate-severe obstructive sleep apnea. 1 Laryngoscope, 2635-2643, 2018.