Journal
SLEEP
Volume 34, Issue 11, Pages 1479-1486Publisher
OXFORD UNIV PRESS INC
DOI: 10.5665/sleep.1380
Keywords
Sleep apnea; hypoglossal nerve stimulation; implantable neurostimulator; genioglossus muscle; lung
Categories
Funding
- National Health and Medical Research Council of Australia (NHMRC) [513704]
- National Center for Research Resources (NCRR) of the National Institutes of Health
- Triological Society of the American Laryngological, Rhinological, and Otological Society
- NHMRC [510392]
- American Heart Association [10SDG3510018]
- Apnex Medical
- Phillips Respironics
- Sepracor Pharmaceuticals
- Respironics Foundation
- ResMed
- Fisher and Paykel
- Compumedics Australia Limited
- Bird (Pyt) Ltd.
- Actelion Pharmaceuticals
- Boehringer-Ingelheim
- Glaxo Smith Kline
- Novartis
- Hunter Immunology
- Sanofi Aventis
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Background: Reduced upper airway muscle activity during sleep is fundamental to obstructive sleep apnea (OSA) pathogenesis. Hypoglossal nerve stimulation (HGNS) counteracts this problem, with potential to reduce OSA severity. Study Objectives: To examine safety and efficacy of a novel HGNS system (HGNS, Apnex Medical, Inc.) in treating OSA. Participants: Twenty-one patients, 67% male, age (mean +/- SD) 53.6 +/- 9.2 years, with moderate to severe OSA and unable to tolerate continuous positive airway pressure (CPAP). Design: Each participant underwent surgical implantation of the HGNS system in a prospective single-arm interventional trial. OSA severity was defined by apnea-hypopnea index (AHI) during in-laboratory polysomnography (PSG) at baseline and 3 and 6 months post-implant. Therapy compliance was assessed by nightly hours of use. Symptoms were assessed using the Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Calgary Sleep Apnea Quality of Life Index (SAQLI), and the Beck Depression Inventory (BDI). Results: HGNS was used on 89% +/- 15% of nights (n = 21). On these nights, it was used for 5.8 +/- 1.6 h per night. Nineteen of 21 participants had baseline and 6-month PSGs. There was a significant improvement (all P < 0.05) from baseline to 6 months in: AHI (43.1 +/- 17.5 to 19.5 +/- 16.7), ESS (12.1 +/- 4.7 to 8.1 +/- 4.4), FOSQ (14.4 +/- 2.0 to 16.7 +/- 2.2), SAQLI (3.2 +/- 1.0 to 4.9 +/- 1.3), and BDI (15.8 +/- 9.0 to 9.7 +/- 7.6). Two serious device-related adverse events occurred: an infection requiring device removal and a stimulation lead cuff dislodgement requiring replacement. Conclusions: HGNS demonstrated favorable safety, efficacy, and compliance. Participants experienced a significant decrease in OSA severity and OSA-associated symptoms. Clinical Trial Information: Name: Australian Clinical Study of the Apnex Medical HGNS System to Treat Obstructive Sleep Apnea. Registration Number: NCT01186926. URL: http://clinicaltrials.govict2/show/NCT01186926.
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