Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea.

ABSTRACT:

Background and aim

Hypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system.

Methods

This prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea-hypopnoea index (AHI). The secondary outcome was the change in the 4% oxygen desaturation index (ODI).

SUBMITTER: Eastwood PR 

PROVIDER: S-EPMC6949509 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature