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Alan R. Schwartz, MD; Marc L. Bennett, MD; Philip L. Smith, MD; Wilfried De Backer, MD; Jan Hedner, MD; An Boudewyns, MD; Paul Van de Heyning, MD; Hasse Ejnell, MD; Walter Hochban, DDS, MD; Lennart Knaack, MD; Thomas Podszus, MD; Thomas Penzel, PhD; J. Hermann Peter, MD; George S. Goding, MD; Donald J. Erickson; Roy Testerman, PhD; Frans Ottenhoff, PhD; David W. Eisele, MD

Arch Otolaryngol Head Neck Surg. 2001;127:1216-1223.

Background  Hypoglossal nerve stimulation has been demonstrated to relieve upper airway obstruction acutely, but its effect on obstructive sleep apnea is not known.

Objective  To determine the response in obstructive sleep apnea to electrical stimulation of the hypoglossal nerve.

Methods  Eight patients with obstructive sleep apnea were implanted with a device that stimulated the hypoglossal nerve unilaterally during inspiration. Sleep and breathing patterns were examined at baseline before implantation and after implantation at 1, 3, and 6 months and last follow-up.

Results  Unilateral hypoglossal nerve stimulation decreased the severity of obstructive sleep apnea throughout the entire study period. Specifically, stimulation significantly reduced the mean apnea-hypopnea indices in non–rapid eye movement (mean ± SD episodes per hour, 52.0 ± 20.4 for baseline nights and 22.6 ± 12.1 for stimulation nights; P<.001) and rapid eye movement (48.2 ± 30.5 and 16.6 ± 17.1, respectively; P<.001) sleep and reduced the severity of oxyhemoglobin desaturations. With improvement in sleep apnea, a trend toward deeper stages of non–rapid eye movement sleep was observed. Moreover, all patients tolerated long-term stimulation at night and did not experience any adverse effects from stimulation. Even after completing the study protocol, the 3 patients who remained free from stimulator malfunction continued to use this device as primary treatment.

Conclusion  The findings demonstrate the feasibility and therapeutic potential for hypoglossal nerve stimulation in obstructive sleep apnea.

From the Johns Hopkins Sleep Disorders Center and Department of Otolaryngology–Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Md (Drs Schwartz, Bennett, Smith, and Eisele); University Hospital Antwerp Sleep Center, Antwerp, Belgium (Drs De Backer, Boudewyns, and Van de Heyning); Departments of Clinical Pharmacology (Dr Hedner) and Otolaryngology–Head and Neck Surgery (Dr Ejnell), Sahlgrenska University Hospital, Goteborg, Sweden; Sleep Medicine Laboratory, Pulmonary Division and Department of Internal Medicine, Hospital of the Phillips University of Marburg, Marburg, Germany (Drs Hochban, Knaack, Podszus, Penzel, and Peter); Department of Otolaryngology–Head and Neck Surgery, Hennepin County Medical Center, University of Minnesota, Minneapolis (Dr Goding); and Medtronic Upper Airway, Minneapolis (Mr Erickson and Dr Testerman), and Maastricht, the Netherlands (Dr Ottenhoff). Drs Schwartz, Smith, Van de Heyning, De Backer, and Eisele have served as medical advisors to Medtronic Inc (Minneapolis, Minn), and Dr Goding is currently a medical advisor to Medtronic Inc. None of the investigators has any financial interest in Medtronic Inc or any of its products.

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