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Randomized Controlled Trial
. 2023 Nov 1;19(11):1905-1912.
doi: 10.5664/jcsm.10712.

Comparison of clinical pathways for hypoglossal nerve stimulation management: in-laboratory titration polysomnography vs home-based efficacy sleep testing

David Kent  1 , Phillip Huyett  2 , Phoebe Yu  2 , Asim Roy  3 , Reena Mehra  4 , Jessica Vensel Rundo  5 , Stephanie Stahl  6 , Shalini Manchanda  7
Affiliations
Randomized Controlled Trial

Comparison of clinical pathways for hypoglossal nerve stimulation management: in-laboratory titration polysomnography vs home-based efficacy sleep testing

David Kent et al. J Clin Sleep Med. .

Abstract

Study objectives: We conducted this study to evaluate whether laboratory or home-based hypoglossal nerve stimulation (HNS) management would have equivalent objective and subjective obstructive sleep apnea outcomes 6 months after activation.

Methods: Patients undergoing standard-of-care HNS implantation were randomly assigned in a prospective, multicenter clinical trial to either a 3-month postactivation in-laboratory titration polysomnography (tPSG) or an efficacy home sleep study (eHST) with tPSG by exception for eHST nonresponders at 5 months. Both groups underwent an eHST 6 months postactivation.

Results: Sixty patients were randomly assigned. Patients experienced equivalent decreases in the apnea-hypopnea index (mean difference: -0.01 events/h [-8.75, 8.74]) across both groups with HNS; the selection of tPSG or eHST did not associate with therapy response rates (tPSG vs eHST: 63.2% vs 59.1%). The Epworth Sleepiness Scale (median of differences: 1 [-1, 3]) and device usage (median of differences: 0.0 hours [-1.3, 1.3]) outcomes were similar but did not meet a priori statistical equivalence criteria.

Conclusions: This prospective, multicenter, randomized clinical trial demonstrated that patients undergoing HNS implantation experienced statistically equivalent improvements in objective obstructive sleep apnea outcomes and similar improvements in daytime sleepiness regardless of whether they underwent tPSG. HNS titration with tPSG may not be required for all postoperative patients.

Clinical trial registration: Registry: ClinicalTrials.gov; Name: Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing) (HOME); URL: https://clinicaltrials.gov/ct2/show/NCT04416542; Identifier: NCT04416542.

Citation: Kent D, Huyett P, Yu P, et al. Comparison of clinical pathways for hypoglossal nerve stimulation management: in-laboratory titration polysomnography vs home-based efficacy sleep testing. J Clin Sleep Med. 2023;19(11):1905-1912.

Keywords: home sleep study; hypoglossal nerve stimulation; in-laboratory polysomnography; obstructive sleep apnea; titration.

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Conflict of interest statement

All authors have read and approved the manuscript. Financial and statistical support was provided by Inspire Medical Systems, Inc. David Kent reports research support from Inspire Medical Systems, Inc., Invicta Medical, Inc., and Nyxoah SA; consulting for Invicta Medical, Inc.; and being a scientific advisory board member of and holding intellectual property interests in Nyxoah SA. Phillip Huyett reports research support from Inspire Medical Systems, Inc. and Nyxoah SA and educational consulting for Inspire Medical Systems, Inc. Asim Roy reports consulting for Jazz Pharmaceuticals, Suven Pharmaceuticals, Inspire Medical Systems, Inc., and Avadel Pharmaceuticals; research support from Jazz Pharmaceuticals, Suven Pharmaceuticals, Inspire Medical Systems, Inc., Nyxoah SA, LivaNova, and Avadel Pharmaceuticals; and being on the speaker’s bureau for Jazz Pharmaceuticals, Eisai Pharmaceuticals, and Harmony Biosciences. Reena Mehra reports receiving honorarium from the American Academy of Sleep Medicine, funds for service on the American Board of Internal Medicine Writing Committee and Associate Editor for the American Journal of Respiratory and Critical Care Medicine, National Institutes of Health funding, and royalties from Up to Date. Shalini Manchanda reports being on the Physician Advisory Council for Inspire Medical Systems, Inc. The other authors report no conflicts of interest.

Figures

Figure 1
Figure 1. Study enrollment, randomization, and attrition.
*Patients may have had more than one reason for study exit. **One patient missed the 5-month tPSG but completed the 6-month follow-up visit. AE = adverse event, eHST = efficacy home sleep apnea test, tPSG = in-laboratory titration polysomnography.
Figure 2
Figure 2. Baseline and 6-month Epworth Sleepiness Scale (ESS) by randomization group.
Box = interquartile range; whiskers = outer quartiles; line = median; x = mean; dots = outliers. eHST = efficacy home sleep apnea test, tPSG = in-laboratory titration polysomnography.
Figure 3
Figure 3. Six-month therapy usage by randomization group.
Box = interquartile range; whiskers = outer quartiles; line = median; x = mean. eHST = efficacy home sleep apnea test, tPSG = in-laboratory titration polysomnography.
See this image and copyright information in PMC

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