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Clinical Trial
. 2001 Oct;127(10):1216-23.
doi: 10.1001/archotol.127.10.1216.

Therapeutic electrical stimulation of the hypoglossal nerve in obstructive sleep apnea

Affiliations
Clinical Trial

Therapeutic electrical stimulation of the hypoglossal nerve in obstructive sleep apnea

A R Schwartz et al. Arch Otolaryngol Head Neck Surg. 2001 Oct.

Abstract

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.

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