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

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.

Personalized multimodal management for severe obstructive sleep apnea in a patient intolerant of positive airway pressure with hypoglossal nerve stimulator and mandibular advancement device.

Treatment of moderate to severe obstructive sleep apnea poses clinical challenges in persons with intolerance or inadequate response to traditional treatment modalities, including positive airway pressure and mandibular advancement devices. Hypoglossal nerve stimulation is a new treatment option, but few management guidelines exist when it is intolerable or ineffective. Combining several treatment modalities has been an effective strategy for improving symptoms, tolerance, and efficacy. We describe a patient intolerant to positive airway pressure therapy who had continued sleepiness, morning headaches, and snoring with a mandibular advancement device. He underwent hypoglossal nerve stimulation implantation but was intolerant of the voltages required to adequately control his obstructive sleep apnea. Multimodal management with hypoglossal nerve stimulation, mandibular advancement device, and positional therapy was successfully implemented to improve sleepiness, nocturnal symptoms, and the apnea-hypopnea index. This case highlights the personalization and adaptability of combination therapy to suit patient needs while effectively controlling obstructive sleep apnea. CITATION: Lowery MM, Rundo JV, Walia HK, Shah V. Personalized multimodal management for severe obstructive sleep apnea in a patient intolerant of positive airway pressure with hypoglossal nerve stimulator and mandibular advancement device. J Clin Sleep Med. 2023;19(2):403-408.

Obstructive sleep apnea basics.

Obstructive sleep apnea (OSA) is a condition caused by repeated episodes of upper airway collapse and obstruction during sleep associated with arousal from sleep with or without oxygen desaturation. OSA is a highly prevalent condition, particularly in individuals with established risk factors and comorbid conditions. Screening for OSA includes a sleep history, review of symptoms, and physical examination, the results of which can identify patients that need testing for OSA. The polysomnogram or home sleep apnea test results aid in the diagnosis of OSA and its severity.

Polysomnography.

Polysomnography refers to a systematic process used to collect physiologic parameters during sleep. A polysomnogram (PSG) is a procedure that utilizes electroencephalogram, electro-oculogram, electromyogram, electrocardiogram, and pulse oximetry, as well as airflow and respiratory effort, to evaluate for underlying causes of sleep disturbances. PSG is considered to be the gold standard for diagnosing sleep-related breathing disorders, which include obstructive sleep apnea (OSA), central sleep apnea, and sleep-related hypoventilation/hypoxia. PSG can also be utilized to evaluate for other sleep disorders, including nocturnal seizures, narcolepsy, periodic limb movement disorder, and rapid eye movement sleep behavior disorder. With recent technological developments, home sleep apnea testing can be done to confirm a diagnosis in patients with a high risk for moderate to severe OSA in the absence of comorbid medical conditions or other suspected sleep disorders.