Springer Nature is making SARS-CoV-2 and COVID-19 research free. View research | View latest news | Sign up for updates

Nerve stimulation for the treatment of obstructive sleep apnea

  • 5 Accesses

Abstract

This review will trace the elements of neurostimulation for obstructive sleep apnea and details on its implementation, efficacy and safety, immediate clinical outcomes, and future prospects. The literature on upper airway neurostimulation was surveyed from July 2013 to July 2019, with a focus on the components of devices, evidence for clinical utility, and adverse events. Current technology is focused on the hypoglossal nerve stimulation (HNS). The most long-term experience is with the Inspire Medical System (Maple Grove, MN USA) which has both FDA and European regulatory approval. Given the inclusion criteria- BMI < 35 (ideally < 32), AHI 15–65/h, and a favorable anterior–posterior velopharyngeal collapse pattern on DISE, across many centers ~ 65% of patients who are intolerant to primary therapy achieve clinical success (AHI < 20/h with a reduction of < 50% in AHI), and more have symptomatic relief. Adverse events are generally mild, often self-limited, with occasional need for uncomplicated surgical adjustments or replacement of the implantable generator. Three other devices are in various phases of development, each with differences in nerve electrodes, implantable components, power sources, proprietary programming, and activation patterns. Hypoglossal nerve stimulation (HNS) is not considered a first-line treatment option. HNS therapy, however, should be considered as one alternative therapeutic option for patients meeting the inclusion criteria when more traditional therapeutic options have been considered.

This is a preview of subscription content, log in to check access.

Fig. 1
Fig. 2

Illustration and inserts are courtesy of Inspire Medical Systems

Fig. 3
Fig. 4

Images are courtesy of Dr. Jan DeBacker

Fig. 5

Source: Inspire Systems Training materials, by permission

References

  1. 1.

    Sleep apnea syndromes. In: Guilleminault, C., Dement WC, editors. Kroc Foundation series, vol. 11, New York: A. R. Liss; 1978.

  2. 2.

    Shepard JW Jr, Buysse DJ, Chesson AL Jr, Dement WC, Goldberg R, Guilleminault C, et al. History of the development of sleep medicine in the United States. J Clin Sleep Med JCSM. 2005;1:61–82.

  3. 3.

    Strohl KP, Cherniack NS, Gothe B. Physiologic basis of therapy for sleep apnea. Am Rev Respir Dis. 1986;134:791–802.

  4. 4.

    Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet. 2014;383:736–47.

  5. 5.

    Morsy NE, Farrag NS, Zaki NFW, Badawy AY, Abdelhafez SA, El-Gilany AH, et al. Obstructive sleep apnea: personal, societal, public health, and legal implications. Rev Environ Health. 2019;34:153–69.

  6. 6.

    Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev. 2011;15:343–56.

  7. 7.

    Sunwoo BY, Light M, Malhotra A. Strategies to augment adherence in the management of sleep-disordered breathing. Respirology. 2019. https://doi.org/10.1111/resp.13589

  8. 8.

    Sher AE, Schechtman KB, Piccirillo JF. The efficacy of surgical modifications of the upper airway in adults with obstructive sleep apnea syndrome. Sleep. 1996;19:156–77.

  9. 9.

    Sommer UJ, Heiser C, Gahleitner C, Herr RM, Hormann K, Maurer JT, et al. Tonsillectomy with uvulopalatopharyngoplasty in obstructive sleep apnea. Dtsch Arztebl Int. 2016;113:1–8.

  10. 10.

    Camacho M, Chang ET, Neighbors CLP, Noller MW, Mack D, Capasso R, et al. Thirty-five alternatives to positive airway pressure therapy for obstructive sleep apnea: an overview of meta-analyses. Expert Rev Respir Med. 2018;12:919–29.

  11. 11.

    Strohl KP, Butler JP, Malhotra A. Mechanical properties of the upper airway. Compr Physiol. 2012;2:1853–72.

  12. 12.

    Eckert DJ, White DP, Jordan AS, Malhotra A, Wellman A. Defining phenotypic causes of obstructive sleep apnea. Identification of novel therapeutic targets. Am J Respir Crit Care Med. 2013;188:996–1004.

  13. 13.

    Strohl M, Strohl K, Palomo JM, Ponsky D. Hypoglossal nerve stimulation rescue surgery after multiple multilevel procedures for obstructive sleep apnea. Am J Otolaryngol. 2016;37:51–3.

  14. 14.

    Heiser C, Thaler E, Boon M, Soose RJ, Woodson BT. Updates of operative techniques for upper airway stimulation. Laryngoscope. 2016;126(Suppl 7):S12–6.

  15. 15.

    Kezirian EJ, Heiser C, Steffen A, Boon M, Hofauer B, Doghramji K, Maurer JT, Sommer JU, Soose RJ, Schwab R, Thaler E, Withrow K, Kominsky A, Larsen CG, HsiaJ Mehra R, Waters T, Strohl K. Previous surgery and hypoglossal nerve stimulation for obstructive sleep apnea. Otolaryngol Head Neck Surg. 2019;161(5):897–903. https://doi.org/10.1177/0194599819856339.

  16. 16.

    Remmers JE, deGroot WJ, Sauerland EK, Anch AM. Pathogenesis of upper airway occlusion during sleep. J Appl Physiol Respir Environ Exerc Physiol. 1978;44:931–8.

  17. 17.

    Popratiloff AS, Streppel M, Gruart A, Guntinas-Lichius O, Angelov DN, Stennert E, et al. Hypoglossal and reticular interneurons involved in oro-facial coordination in the rat. J Comp Neurol. 2001;433:364–79.

  18. 18.

    Streppel M, Popratiloff A, Gruart A, Angelov DN, Guntinas-Lichius O, Delgado-Garcia JM, et al. Morphological connections between the hypoglassal and facial nerve in the brain stem of the rat. HNO. 2000;48:911–6.

  19. 19.

    Ates S, Karakurum E, Dursun N. Origin, course and distribution of the hypoglossal nerve in the New Zealand rabbit (Oryctolagus cuniculus L). Anat Histol Embryol. 2011;40:360–4.

  20. 20.

    Mediano O, Romero-Peralta S, Resano P, Cano-Pumarega I, Sanchez-de-la-Torre M, Castillo-Garcia M, et al. Obstructive sleep apnea: emerging treatments targeting the genioglossus muscle. J Clin Med. 2019;8:1754.

  21. 21.

    Heiser C, Knopf A, Hofauer B. Surgical anatomy of the hypoglossal nerve: a new classification system for selective upper airway stimulation. Head Neck. 2017;39:2371–80.

  22. 22.

    Eichler C, Sommer JU, Stuck BA, Hormann K, Maurer JT. Does drug-induced sleep endoscopy change the treatment concept of patients with snoring and obstructive sleep apnea. Sleep Breath Schlaf Atm. 2013;17:63–8.

  23. 23.

    De Vito A, Carrasco Llatas M, Vanni A, Bosi M, Braghiroli A, Campanini A, et al. European position paper on drug-induced sedation endoscopy (DISE). Sleep Breath Schlaf Atm. 2014;18:453–65.

  24. 24.

    Van de Heyning PH, Badr MS, Baskin JZ, Cramer Bornemann MA, De Backer WA, Dotan Y, et al. Implanted upper airway stimulation device for obstructive sleep apnea. Laryngoscope. 2012;122:1626–33.

  25. 25.

    Vanderveken OM, Maurer JT, Hohenhorst W, Hamans E, Lin HS, Vroegop AV, et al. Evaluation of drug-induced sleep endoscopy as a patient selection tool for implanted upper airway stimulation for obstructive sleep apnea. J Clin Sleep Med JCSM. 2013;9:433–8.

  26. 26.

    Vroegop AV, Vanderveken OM, Van de Heyning PH, Braem MJ. Effects of vertical opening on pharyngeal dimensions in patients with obstructive sleep apnoea. Sleep Med. 2012;13:314–6.

  27. 27.

    Steffen A, Frenzel H, Wollenberg B, Konig IR. Patient selection for upper airway stimulation: is concentric collapse in sleep endoscopy predictable? Sleep Breath. 2015;19:1373–6.

  28. 28.

    Borek RC, Thaler ER, Kim C, Jackson N, Mandel JE, Schwab RJ. Quantitative airway analysis during drug-induced sleep endoscopy for evaluation of sleep apnea. Laryngoscope. 2012;122:2592–9.

  29. 29.

    Vroegop AV, Vanderveken OM, Boudewyns AN, Scholman J, Saldien V, Wouters K, et al. Drug-induced sleep endoscopy in sleep-disordered breathing: report on 1,249 cases. Laryngoscope. 2014;124:797–802.

  30. 30.

    ElShebiny T, Venkat D, Strohl K, Hans MG, Alonso A, Palomo JM. Hyoid arch displacement with hypoglossal nerve stimulation. Am J Respir Crit Care Med. 2017;196:790–2.

  31. 31.

    Weidenbecher M, Tamaki A, Cabrera C, Strohl K. Improved exposure of the hypoglossal branches during hypoglossal nerve stimulator implantation: clinical outcomes of twenty patients at a single institution. Clin Otolaryngol. 2019;44:72–6.

  32. 32.

    Heiser C, Thaler E, Soose RJ, Woodson BT, Boon M. Technical tips during implantation of selective upper airway stimulation. Laryngoscope. 2018;128:756–62.

  33. 33.

    Thaler E, Schwab R, Maurer J, Soose R, Larsen C, Stevens S, Stevens D, Boon M, Huntley C, Doghramji K, Waters T, Kominsky A, Steffen A, Kezirian E, Hofauer B, Sommer U, Withrow K, Strohl K, Heiser C. Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy. Laryngoscope. 2019. https://doi.org/10.1002/lary.28286

  34. 34.

    Ong AA, O’Brien TX, Nguyen SA, Gillespie MB. Implantation of a defibrillator in a patient with an upper airway stimulation device. Laryngoscope. 2016;126:E86–9.

  35. 35.

    Woodson BT, Gillespie MB, Soose RJ, Maurer JT, de Vries N, Steward DL, et al. Randomized controlled withdrawal study of upper airway stimulation on OSA: short- and long-term effect. Otolaryngol Head Neck Surg. 2014;151:880–7.

  36. 36.

    Soose RJ, Woodson BT, Gillespie MB, Maurer JT, de Vries N, Steward DL, et al. Upper Airway Stimulation For Obstructive Sleep Apnea: Self-Reported Outcomes at 24 months. J Clin Sleep Med. 2016;12:43–8.

  37. 37.

    Woodson BT, Soose RJ, Gillespie MB, Strohl KP, Maurer JT, de Vries N, et al. Three-year outcomes of cranial nerve stimulation for obstructive sleep apnea: the STAR trial. Otolaryngol Head Neck Surg. 2016;154:181–8.

  38. 38.

    Woodson BT, Strohl KP, Soose RJ, Gillespie MB, Maurer JT, de Vries N, et al. Upper airway stimulation for obstructive sleep apnea: 5-year outcomes. Otolaryngol Head Neck Surg. 2018;159:194–202.

  39. 39.

    Steffen A, Sommer JU, Hofauer B, Maurer JT, Hasselbacher K, Heiser C. Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study. Laryngoscope. 2018;128:509–15.

  40. 40.

    Heiser C, Steffen A, Boon M, Hofauer B, Doghramji K, Maurer JT, et al. Post-approval upper airway stimulation predictors of treatment effectiveness in the ADHERE registry. Eur Respir J. 2019;53:1801405.

  41. 41.

    Withrow K, Evans S, Harwick J, Kezirian E, Strollo P. Upper airway stimulation response in older adults with moderate to severe obstructive sleep apnea. Otolaryngol Head Neck Surg. 2019;161(4):714–9. https://doi.org/10.1177/0194599819848709.

  42. 42.

    Hasselbacher K, Hofauer B, Maurer JT, Heiser C, Steffen A, Sommer JU. Patient-reported outcome: results of the multicenter German post-market study. Eur Arch Otorhinolaryngol. 2018;275:1913–9.

  43. 43.

    Walia HK, Thompson NR, Strohl KP, Faulx MD, Waters T, Kominsky A, Foldvary-Schaefer N, Mehra R. Upper airway stimulation vs positive airway pressure impact on BP and sleepiness symptoms in OSA. Chest. 2020;157(1):173–183. https://doi.org/10.1016/j.chest.2019.06.020.

  44. 44.

    Kezirian EJ, Goding GS Jr, Malhotra A, O’Donoghue FJ, Zammit G, Wheatley JR, et al. Hypoglossal nerve stimulation improves obstructive sleep apnea: 12-month outcomes. J Sleep Res. 2014;23:77–83.

  45. 45.

    Zaidi FN, Meadows P, Jacobowitz O, Davidson TM. Tongue anatomy and physiology, the scientific basis for a novel targeted neurostimulation system designed for the treatment of obstructive sleep apnea. Neuromodulation. 2013;16:376–86 (discussion 86).

  46. 46.

    Friedman M, Jacobowitz O, Hwang MS, Bergler W, Fietze I, Rombaux P, et al. Targeted hypoglossal nerve stimulation for the treatment of obstructive sleep apnea: Six-month results. Laryngoscope. 2016;126:2618–23.

  47. 47.

    Mwenge GB, Rombaux P, Dury M, Lengele B, Rodenstein D. Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study. Eur Respir J. 2013;41:360–7.

  48. 48.

    Rodenstein D, Rombaux P, Lengele B, Dury M, Mwenge GB. Residual effect of THN hypoglossal stimulation in obstructive sleep apnea: a disease-modifying therapy. Am J Respir Crit Care Med. 2013;187:1276–8.

  49. 49.

    Sommer JU, Hormann K. Innovative surgery for obstructive sleep apnea: nerve stimulator. Adv Otorhinolaryngol. 2017;80:116–24.

  50. 50.

    Certal VF, Zaghi S, Riaz M, Vieira AS, Pinheiro CT, Kushida C, et al. Hypoglossal nerve stimulation in the treatment of obstructive sleep apnea: a systematic review and meta-analysis. Laryngoscope. 2015;125:1254–64.

  51. 51.

    Kompelli AR, Ni JS, Nguyen SA, Lentsch EJ, Neskey DM, Meyer TA. The outcomes of hypoglossal nerve stimulation in the management of OSA: a systematic review and meta-analysis. World J Otorhinolaryngol Head Neck Surg. 2019;5:41–8.

  52. 52.

    Pietzsch JB, Liu S, Garner AM, Kezirian EJ, Strollo PJ. Long-term cost-effectiveness of upper airway stimulation for the treatment of obstructive sleep apnea: a model-based projection based on the STAR trial. Sleep. 2015;38:735–44.

  53. 53.

    Steffen A, Abrams N, Suurna MV, Wollenberg B, Hasselbacher K. Upper-airway stimulation before, after, or without uvulopalatopharyngoplasty: a two-year perspective. Laryngoscope. 2019;129:514–8.

  54. 54.

    Diercks GR, Wentland C, Keamy D, Kinane TB, Skotko B, de Guzman V, Grealish E, Dobrowski J, Soose R, Hartnick CJ. Hypoglossal nerve stimulation in adolescents with down syndrome and obstructive sleep apnea. JAMA Otolaryngol Head Neck Surg. 2018;144(1):37–42. https://doi.org/10.1001/jamaoto.2017.1871.

  55. 55.

    Caloway CL, Diercks GR, Keamy D, de Guzman V, Soose R, Raol N, Shott SR, Ishman SL, Hartnick CJ. Update on hypoglossal nerve stimulation in children with down syndrome and obstructive sleep apnea. Laryngoscope. 2019. https://doi.org/10.1002/lary.28138.

  56. 56.

    Shah J, Russell JO, Waters T, Kominsky AH, Trask D. Uvulopalatopharyngoplasty vs CN XII stimulation for treatment of obstructive sleep apnea: a single institution experience. Am J Otolaryngol. 2018;39:266–70.

  57. 57.

    Yu JL, Mahmoud A, Thaler ER. Transoral robotic surgery versus upper airway stimulation in select obstructive sleep apnea patients. Laryngoscope. 2019;129:256–8.

  58. 58.

    Strollo PJ Jr, Soose RJ, Maurer JT, de Vries N, Cornelius J, Froymovich O, et al. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med. 2014;370:139–49.

Download references

Acknowledgements

This is original work and has not been published or submitted elsewhere. Based on a April 15th 2019 presentation (KPS) at the 148th WPI-IIIS Seminar, University of Tsukuba, International Institute for Integrative Sleep Medicine, Tsukuba, Japan.

Funding

Funding was provided by NIH-SPARC (Grant no. 1U18EB021792).

Author information

Drs. Yamauchi, Satoh, and Strohl developed the concept for the submission, worked the first drafts, and edited the final submitted report. Addtionally, Dr. Satohl provided insight into the regulatory processes and limits of implementation in Japan. Drs. Kitahara and Ota provided the review of the criteria and procedures relevant to the surgical implant. All authors were involved in the editing and the approval of the final submission.

Correspondence to Kingman Strohl.

Ethics declarations

Conflict of interest

Inspire Medical Systems site PI and consulting (KPS); Sommetrics, Seven Dreamers, Takeda, Jazz, and Merck (KPS).

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Yamauchi, M., Satoh, M., Kitahara, T. et al. Nerve stimulation for the treatment of obstructive sleep apnea. Sleep Biol. Rhythms (2020). https://doi.org/10.1007/s41105-020-00252-2

Download citation

Keywords

  • Obstructive sleep apnea
  • Nerve stimulation
  • Upper airway function
  • OSA treatment