Premium
Hypoglossal nerve stimulation improves obstructive sleep apnea: 12‐month outcomes
Author(s) -
Kezirian Eric J.,
Goding George S.,
Malhotra Atul,
O'Donoghue Fergal J.,
Zammit Gary,
Wheatley John R.,
Catcheside Peter G.,
Smith Philip L.,
Schwartz Alan R.,
Walsh Jennifer H.,
Maddison Kathleen J.,
Claman David M.,
Huntley Tod,
Park Steven Y.,
Campbell Matthew C.,
Palme Carsten E.,
Iber Conrad,
Eastwood Peter R.,
Hillman David R.,
Barnes Maree
Publication year - 2014
Publication title -
journal of sleep research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.297
H-Index - 117
eISSN - 1365-2869
pISSN - 0962-1105
DOI - 10.1111/jsr.12079
Subject(s) - hypoglossal nerve , obstructive sleep apnea , medicine , stimulation , physical medicine and rehabilitation , sleep apnea , anesthesia , tongue , pathology
Summary Reduced upper airway muscle activity during sleep is a key contributor to obstructive sleep apnea pathogenesis. Hypoglossal nerve stimulation activates upper airway dilator muscles, including the genioglossus, and has the potential to reduce obstructive sleep apnea severity. The objective of this study was to examine the safety, feasibility and efficacy of a novel hypoglossal nerve stimulation system ( HGNS ® ; Apnex Medical, St Paul, MN , USA ) in treating obstructive sleep apnea at 12 months following implantation. Thirty‐one subjects (35% female, age 52.4 ± 9.4 years) with moderate to severe obstructive sleep apnea and unable to tolerate positive airway pressure underwent surgical implantation and activation of the hypoglossal nerve stimulation system in a prospective single‐arm interventional trial. Primary outcomes were changes in obstructive sleep apnea severity (apnea–hypopnea index, from in‐laboratory polysomnogram) and sleep‐related quality of life [Functional Outcomes of Sleep Questionnaire ( FOSQ )]. Hypoglossal nerve stimulation was used on 86 ± 16% of nights for 5.4 ± 1.4 h per night. There was a significant improvement ( P < 0.001) from baseline to 12 months in apnea–hypopnea index (45.4 ± 17.5 to 25.3 ± 20.6 events h −1 ) and Functional Outcomes of Sleep Questionnaire score (14.2 ± 2.0 to 17.0 ± 2.4), as well as other polysomnogram and symptom measures. Outcomes were stable compared with 6 months following implantation. Three serious device‐related adverse events occurred: an infection requiring device removal; and two stimulation lead cuff dislodgements requiring replacement. There were no significant adverse events with onset later than 6 months following implantation. Hypoglossal nerve stimulation demonstrated favourable safety, feasibility and efficacy.