Importance: Evidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA).
Objective: To evaluate the safety and effectiveness of targeted hypoglossal nerve stimulation (THN) of the proximal hypoglossal nerve in patients with OSA.
Design, Setting, And Participants: This randomized clinical trial (THN3) was conducted at 20 centers and included 138 patients with moderate to severe OSA with an apnea-hypopnea index (AHI) of 20 to 65 events per hour and body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or less.
Background: Existing evaluative instruments for dysphagia, odynophagia, and voice disturbance are cumbersome, focus pre-dominately on dysphagia, and often require administration by a certified Speech Pathologist. This study was conducted to utilize widely accepted instruments such as the American Speech and Hearing Association's National Outcomes Measurement System (NOMS) and VAS pain scales to validate a novel, patient-reported instrument that quantifies the severity of post-operative dysphagia, odynophagia, and voice disabilities (DOV).
Methods: The DOV was developed and subjected to multiple rounds of face and content validation by representative patient cohorts and a panel of clinical experts.