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Therapeutic Electrical Stimulation of the Hypoglossal Nerve in Obstructive Sleep Apnea
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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