Outcome Reporting in Prospective Studies Evaluating Neurostimulation for Obstructive Sleep Apnea.

Abstract

Due to the controversy surrounding the appropriate outcomes in neurostimulation, we sought to systematically describe ways in which polysomnography and apnea-hypopnea index are reported in prospective studies involving unilateral hypoglossal nerve stimulation. MEDLINE (Ovid), Embase (Ovid), Cochrane Library, and Scopus. Following the Preferred Reporting items of Systematic Reviews and Meta-analysis (PRISMA) Statement guidelines, a systematic two-reviewer system was used for study screening and quality assessment. Articles that met inclusion criteria were included. Quality was evaluated with either the Newcastle-Ottawa Quality Assessment Scale or the Covidence risk-of-bias tool. Fifteen studies met the inclusion criteria, which included 14 prospective cohort studies and one randomized controlled trial. Titration polysomnography was the primary sleep study used to acquire data in five of the studies compared to only three studies employing exclusively non-titration polysomnography to report outcomes. Three studies compiled data from two or more sleep studies to report a single apnea-hypopnea index. Within the 15 studies, non-titration apnea-hypopnea index was the most reported type (five studies). Titration apnea-hypopnea index was used to report outcomes in one study. Five studies did not specify what type of apnea-hypopnea index was employed to report treatment effectiveness. The reported sleep studies and corresponding apnea-hypopnea indices were highly variable across the studies. Because of the high degree of heterogeneity, future research would benefit from consistent use of a standardized apnea-hypopnea index to report outcomes related to hypoglossal nerve stimulation. NA Laryngoscope, 2024.