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Original Investigation
September 26, 2019

Evaluation of Hypoglossal Nerve Stimulation Treatment in Obstructive Sleep Apnea

Author Affiliations
  • 1Department of Otolaryngology, Vanderbilt University Medical Center, Nashville, Tennessee
  • 2Sleep Specialists, St Thomas Medical Partners, Nashville, Tennessee
  • 3Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee
  • 4Department of Otolaryngology–Head & Neck Surgery, University of Cincinnati, Cincinnati, Ohio
JAMA Otolaryngol Head Neck Surg. Published online September 26, 2019. doi:10.1001/jamaoto.2019.2723
Key Points

Question  What factors are associated with response to hypoglossal nerve stimulation treatment of obstructive sleep apnea across multiple clinical cohorts?

Findings  In this pooled cohort analysis of 4 observational cohorts comprising 584 patients, greater postoperative improvement in the apnea-hypopnea index was found to be associated with higher preoperative apnea-hypopnea index, older patient age, and lower body mass index.

Meaning  Hypoglossal nerve stimulation was associated with clinically significant improvements in obstructive sleep apnea severity, daytime sleepiness, and sleep-related quality of life, and patient characteristics were associated with degree of improvement.

Abstract

Importance  Hypoglossal nerve stimulation is a treatment option for patients with obstructive sleep apnea unable to tolerate continuous positive airway pressure. This study evaluates demographic factors that may be associated with greater improvements in postoperative outcomes of interest.

Objective  To examine the association of hypoglossal nerve stimulation with obstructive sleep apnea severity, daytime sleepiness, and sleep-related quality of life.

Design, Setting, and Participants  Patient-level data were pooled from 3 prospective cohorts and 1 retrospective observational cohort comprising 584 adults with moderate to severe obstructive sleep apnea unable to tolerate or benefit from continuous positive airway pressure. The data were gathered from the Stimulation Therapy for Apnea Reduction Trial; a postmarket approval study conducted in Germany; the multicenter, international Adherence and Outcome of Upper Airway Stimulation for OSA Registry; and a retrospective cohort study from 2 sites in the United States.

Exposure  Hypoglossal nerve stimulation.

Main Outcomes and Measures  Severity of obstructive sleep apnea was the primary outcome. The apnea-hypopnea index (AHI) (<5, normal; 5-15, mild; 15-30, moderate, and >30, severe) and Epworth Sleepiness Scale (range, 0-24; score >10 indicates pathologic sleepiness) outcomes were available at 2 to 6 months from 2 cohorts (n = 398), at 12 months from 1 cohort (n = 126), and at both times from 1 cohort (n = 60). Sleep-related quality of life and oxygen saturation nadir data were collected where available. Linear mixed-effects models were constructed to examine associations between clinical variables and reported postoperative outcomes at 6 and 12 months with study included as a random effect.

Results  Of the 584 patients included in the study, 472 were men (80.8%); mean (SD) age was 58.5 (11.0) years. Greater improvement in the postoperative AHI was associated with a higher preoperative AHI (−0.74 events/h; 95% CI, −0.82 to −0.67), older patient age (−0.10 events/h; 95% CI, −0.20 to −0.00), and lower body mass index (0.52; 95% CI, 0.22-0.83). After adjusting for these variables and considering all patients in the analysis, the AHI was statistically higher at 12 months than at 6 months (3.24 events/h; 95% CI, 1.67-4.82 events/h).

Conclusions and Relevance  Hypoglossal nerve stimulation demonstrated clinically significant improvements in obstructive sleep apnea severity, daytime sleepiness, and sleep-related quality of life in this pooled cohort of patient-level results. Age, body mass index, and preoperative AHI appeared to be associated with treatment outcomes, and these variables may explain some of the difference between 2- to 6-month and 12-month outcomes.

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