Implantable Hypoglossal Nerve Stimulation
Hypoglossal nerve stimulation is proposed as a treatment for obstructive sleep apnea in individuals who are unable to use CPAP. Stimulation of the hypoglossal nerve contracts the genioglossus muscle causing tongue protrusion and stiffening of the anterior pharyngeal wall, potentially decreasing apneic events. Implantable hypoglossal nerve stimulation systems, such as the Inspire® II Upper Airway Stimulation System, include respiratory sensing leads that permit intermittent stimulation during inspiration. Stimulation parameters are titrated during an in-laboratory polysomnography and can be adjusted by the patient during home use. The device is turned on only during sleep periods.
Implantable hypoglossal nerve stimulators are considered investigational for all indications, including but not limited to the treatment of obstructive sleep apnea.
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The role of hypoglossal nerve stimulation among the surgical procedures for obstructive sleep apnea is uncertain. Randomized controlled trials comparing hypoglossal nerve stimulation to conventional surgical procedures are necessary to evaluate benefits and harms. The evidence is insufficient to determine the effects of the technology on health outcomes.
American Academy of Otolaryngology – Head and Neck Surgery. (2016). Position statement: hypoglossal nerve stimulation for treatment of obstructive sleep apnea (OSA). Retrieved July 10, 2017 from http://www.entnet.org/content/position-statement-hypoglossal-nerve-stimulation-treatment-obstructive-sleep-apnea-osa.
American Academy of Sleep Medicine. (2009). Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. Retrieved July 10, 2017 from http://www.aasmnet.org/Resources/clinicalguidelines/OSA_Adults.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (12:2016). Surgical treatment of snoring and obstructive sleep apnea. Retrieved August 2, 2018 from BlueWeb. (32 articles and/or guidelines reviewed)
Certal, V., Zaghi, S., Riaz, M., Vieira, A., Pinheiro, C., Kushida, C, et al. (2015). Hypoglossal nerve stimulation in the treatment of obstructive sleep apnea: a systematic review and meta-analysis. Laryngoscope, 125 (5), 1254-1264. Abstract retrieved July 10, 2017 from PubMed database.
Gillespie, M., Soose, R., Woodson, B., Strohl, K., Maurer, J., de Vries, N., et al. (2017). Upper airway stimulation for obstructive sleep apnea: patient-reported outcomes after 48 months of follow-up. Otolaryngology - Head Neck Surgery, 156 (4), 7658-771. Abstract retrieved July 14, 2017 from PubMed database.
Soose, R., Woodson, B., Gillespie, M., Maurer, J., de Vries, N., Steward, D., (2016). Upper airway stimulation for obstructive sleep apnea: self-reported outcomes at 24 months. Journal of Clinical Sleep Medicine, 12 (1), 43-48. (Level 3 evidence)
Steffen, A., Sommer, J., Hofauer, B., Maurer, J., Hasselbacher, K., & Heiser, C. (2017). Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study. The Laryngoscope, 2017 May 31. Doi: 10.1002/lary.26688. [Epub ahead of print]. (Level 4 evidence)
Strollo, P., Gillespie, M., Soose, R., Maurer, J., de Vries, N., Cornelius, J., et al. (2015). Upper airway stimulation for obstructive sleep apnea: durability of the treatment effect at 18 months. Sleep, 38 (10), 1593-1598C. (Level 3 evidence)
Strollo, P., Soose, R., Maurer, J., de Vries, N., Cornelius, J., Froymovich, O., et al. (2014). Upper-airway stimulation for obstructive sleep apnea. The New England Journal of Medicine, 370, 139-149. (Level 3 evidence)
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, March; last update search February 2018). Hypoglossal nerve stimulation for the treatment of obstructive sleep apnea. Retrieved August 2, 2018 from www.haysinc.com (57 articles and/or guidelines reviewed)
Woodson, B., Soose, R., Gillespie, M., Strohl, K., Maurer, J., de Vries, N., et al. (2016). Three-year outcomes of cranial nerve stimulation for obstructive sleep apnea: the STAR trial. Otolaryngology – Head and Neck Surgery, 154 (1), 181-188. (Level 3 evidence)
ORIGINAL EFFECTIVE DATE: 12/1/2017
MOST RECENT REVIEW DATE: 9/13/2018
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