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Review
. 2016 Jul;54(4):241-9.
doi: 10.1016/j.resinv.2016.01.006. Epub 2016 Mar 18.

Origins of and implementation concepts for upper airway stimulation therapy for obstructive sleep apnea

Kingman P Strohl M D  1 , Jonathan Baskin M D  2 , Colleen Lance M D  3 , Diana Ponsky M D  4 , Mark Weidenbecher M D  5 , Madeleine Strohl B A  6 , Motoo Yamauchi M D  7
Affiliations
Review

Origins of and implementation concepts for upper airway stimulation therapy for obstructive sleep apnea

Kingman P Strohl M D et al. Respir Investig. 2016 Jul.

Abstract

Upper airway stimulation, specifically hypoglossal (CN XII) nerve stimulation, is a new, alternative therapy for patients with obstructive sleep apnea hypopnea syndrome who cannot tolerate positive airway pressure, the first-line therapy for symptomatic patients. Stimulation therapy addresses the cause of inadequate upper airway muscle activation for nasopharyngeal and oropharyngeal airway collapse during sleep. The purpose of this report is to outline the development of this first-in-class therapy and its clinical implementation. Another practical theme is assessment of the features for considering a surgically implanted device and the insight as to how both clinical and endoscopic criteria increase the likelihood of safe and durable outcomes for an implant and how to more generally plan for management of CPAP-intolerant patients. A third theme is the team building required among sleep medicine and surgical specialties in the provision of individualized neurostimulation therapy.

Keywords: Genioglossus; Hypoglossal nerve; Neurotherapeutics; Pharynx; Sleep apnea.

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Conflict of interest statement

Conflict of interest

Kingman P. Strohl served as a site Principal Investigatorfor the STAR trial and advisor to the FDA application in 2014 for the Inspire Medical System and received research grants from the VA Research Service and the National Institute of Health. Other authors have no conflict of interest.

Figures

Figure 1
Figure 1
The four pathogenic pathways that in combination lead to recurrent OSA and to the development of the syndrome. If inadequate muscle activation could be reversed, even by itself, recurrent sleep apnea could be reversed at least in a subset of patients. Upper airway muscle and nerve stimulations are collectively called neurotherapeutics.
Figure 2
Figure 2
In this strip chart polysomnogram recording (approximately 2 minutes), the stimulator is turned ON (as verified by the bursting of the chin EMG and then turned OFF, and then turned ON again. Abruptly, when the stimulator is turned OFF, there is upper airway obstruction, as illustrated by the flat nasal pressure signal, continued respiratory efforts, and a fall in oxygen saturation. (The thermistor signal is a thermal drift.) EEG = electroencephalogram. EOG = electrooculogram or eye movements. EMG = chin electromyogram. Snore = snore signal by microphone. THERM = thermistor at the nose for airflow. Nasal = nasal pressure transducer for flow. Chest and Abdm = chest and abdomen efforts, respectively, by inductance methods. SaO2 = oxygen saturation by oximetry.
Figure 3
Figure 3
These bars represent the results of the STAR trial for the Inspire therapy from baseline to 36 months. The median values (as the data are not normally distributed) of the apnea-hypopnea index and oxygen desaturation index are provided in the bar graph on the right. The subjective outcomes of the Epworth Sleepiness Scale (ESS) and functional outcomes of sleep questionnaire are also shown. There are significant differences (p < 0.001) between the baseline and each of the time points. Further discussion of the results is in the review.
Figure 4
Figure 4
The concepts for the development of a case management plan for a center in terms of patient flow (left column) and system issues (right column).
See this image and copyright information in PMC

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