Comparison of clinical pathways for hypoglossal nerve stimulation management: in-laboratory titration polysomnography versus home-based efficacy sleep testing.

Abstract

To evaluate whether laboratory or home-based hypoglossal nerve stimulation (HNS) management would have equivalent objective and subjective obstructive sleep apnea (OSA) outcomes 6 months after activation. Patients undergoing standard-of-care HNS implantation were randomized in a prospective, multicenter clinical trial to either a 3-month post-activation in-laboratory titration polysomnography (tPSG) or an efficacy home sleep study (eHST) with tPSG by exception for eHST non-responders at 5 months. Both arms underwent an eHST 6 months post-activation. Sixty patients were randomized. Patients experienced equivalent decreases in the apnea-hypopnea index (Mean difference: -0.01 events/hr [-8.75, 8.74]) across both arms with HNS; the selection of tPSG or eHST did not associate with therapy response rates (tPSG vs eHST: 63.2% vs 59.1%). The Epworth Sleepiness Scale (median of differences: 1 [-1, 3]) and device usage (median of differences: 0.0 h [-1.3, 1.3]) outcomes were similar but did not meet a priori statistical equivalence criteria. This prospective, multicenter, randomized clinical trial demonstrated that patients undergoing HNS implantation experienced statistically equivalent improvements in objective OSA outcomes and similar improvements in daytime sleepiness regardless of whether they underwent tPSG. HNS titration with tPSG may not be required for all postoperative patients. Registry: ClinicalTrials.gov; Identifier: NCT04416542.