Acute Upper Airway Responses to Hypoglossal Nerve Stimulation during Sleep in Obstructive Sleep Apnea (original) (raw)
Related papers
JAMA Otolaryngology–Head & Neck Surgery, 2020
bstructive sleep apnea (OSA) is a disorder that involves complete or partial blockage in airflow during sleep. The resulting hypoxia and sympathetic activation place patients at an increased risk for metabolic syndrome, neurocognitive decline, hypertension, stroke, and other cardiovascular sequelae. 1,2 The primary therapy for OSA is positive airway pressure (PAP); however, although PAP treatment is beneficial, recommended adherence to therapy ranges from 17% to 54%. 3 Consequently, there exists a need for treatment alternatives to PAP therapy. One class of alternatives to PAP therapy is upper airway surgery, which includes soft tissue surgery, skeletal surgery, tracheostomy, and hypoglossal nerve stimulation (HGNS). Hypoglossal nerve stimulation, the most recent development in OSA surgery, involves stimulation of select branches of the hypoglossal nerve resulting in tongue protrusion and upper airway dilation during sleep. The HGNS device used consists of 3 implantable components: a respiratory sensor, pulse generator (battery), and an electrode cuff (Inspire; Inspire Medical Systems). Upon inspiration, the respiratory sensor detects changes in the intrathoracic space and signals the pulse generator to stimulate the hypoglossal nerve. Stimulation persists through the end of expiration and then briefly deactivates to avoid overstimulation. Although studies have cited significant improvements in both objective and subjective outcomes following HGNS, 4-6 there exists a need to determine factors predictive of surgical outcomes. A previous study showed that a therapeutic PAP IMPORTANCE Recent retrospective hypoglossal nerve stimulation (HGNS) outcomes data suggest that patients with low therapeutic positive airway pressure (PAP) levels achieve greater success than patients with high therapeutic PAP levels. OBJECTIVE To examine the use of therapeutic nasal PAP levels at the soft palate in predicting the outcomes of HGNS for patients with obstructive sleep apnea. DESIGN, SETTING, AND PARTICIPANTS This prospective cohort study used drug-induced sleep endoscopy (DISE) to evaluate the predictive capacity of therapeutic PAP levels in HGNS outcomes. In an academic sleep surgery center, 27 consecutive patients with obstructive sleep apnea who underwent DISE before implantation of an HGNS device were evaluated. The study was conducted from May 1, 2018, to June 26, 2019. EXPOSURES Positive airway pressure delivered through a nasal mask during DISE. MAIN OUTCOMES AND MEASURES Improvement in apnea-hypopnea index as measured from full-night preoperative and postoperative efficacy studies. RESULTS Twenty-seven patients met all inclusion criteria. The mean (SD) age was 62.0 (14.4) years, 14 participants were men (51.9%), and mean body mass index was 28.1 (4.0). Responders to HGNS therapy (n = 18) had significantly lower mean (SD) palatal opening pressure compared with nonresponders (n = 9) (5.0 [2.8] vs 9.2 [3.7] cm H 2 O, respectively; mean difference, −4.2; 95% CI, −6.8 to −1.6 cm H 2 O). After adjusting for age, sex, and body mass index, the mean palatal opening pressure value for the responders remained 3.5 cm H 2 O lower (95% CI, −6.7 to −0.4 cm H 2 O) than that of nonresponders. A palatal opening pressure cutoff level less than 8 cm H 2 O demonstrated a positive predictive value of 82.4%; sensitivity, 77.8%; and specificity, 66.7%. CONCLUSIONS AND RELEVANCE In this small prospective cohort study, therapeutic nasal PAP levels during DISE differed significantly between responder and nonresponders to HGNS. Because DISE represents a mandatory, relatively standardized diagnostic tool for HGNS candidacy, the use of therapeutic nasal PAP through DISE can be broadly implemented and studied across multiple centers to possibly improve patient selection for HGNS.
Hypoglossal-Nerve Stimulation for Obstructive Sleep Apnea
New England Journal of Medicine, 2014
Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol 2013 April 14 (Epub ahead of print). 3. Weaver TE, Mancini C, Maislin G, et al. Continuous positive airway pressure treatment of sleepy patients with milder obstructive sleep apnea: results of the CPAP Apnea Trial North American Program (CATNAP) randomized clinical trial. Am J
Bilateral Hypoglossal Nerve Stimulation for Treatment of Adult Obstructive Sleep Apnea
European Respiratory Journal
Background and AimHypoglossal Nerve Stimulation (HNS) decreases Obstructive Sleep Apnea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system.MethodsThis prospective, open-label, non-randomised, single arm treatment study was conducted at eight centres in three countries (Australia, France, UK). Primary outcomes were incidence of device-related Serious Adverse Events (SAEs) and change in the Apnea-Hypopnea Index (AHI). The secondary outcome was the change in the 4% Oxygen Desaturation Index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring, and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604.ResultsFrom 27 implanted participants (63% male, aged 55.9±12.0 yea...
Hypoglossal nerve stimulation versus positive airway pressure therapy for obstructive sleep apnea
Sleep and Breathing, 2022
Purpose Hypoglossal nerve stimulation (HNS) has been shown to treat obstructive sleep apnea (OSA) effectively. The aim of this study was to compare HNS with positive airway pressure (PAP) treatment regarding outcome parameters: (1) sleepiness, (2) apnea-hypopnea index (AHI), and (3) effectiveness. Methods Propensity score matching with nearest neighbor algorithm was used to compare outcomes of HNS and PAP therapy in a real-world setting. Data were collected at baseline and 12 months after initiating OSA treatment including demographics, Epworth Sleepiness Scale (ESS), AHI, and objective adherence data. To account for overall treatment efficacy, the mean disease alleviation (MDA) was calculated. Results Of 227 patients who received treatment consecutively, 126 could be matched 1:1 with regard to age, body mass index, and AHI. After matching, no statistically significant differences between the groups were found. A clinically important symptom improvement was seen at 12 months in both cohorts, though there was a greater difference in ESS improvement in patients treated with HNS (8.0 ± 5.1 points vs. 3.9 ± 6.8 points; p = 0.042). In both groups, mean posttreatment AHI was significantly reduced (HNS: 8.1 ± 6.3/h; PAP: 6.6 ± 8.0/h; p < 0.001). Adherence after 12 months among patients treated with HNS was higher than in those receiving PAP therapy (5.0 ± 2.6 h/night; 4.0 ± 2.1 h/night) but not with statistical significance. Overall effectiveness calculated with the MDA was 59% in patients treated with HNS compared to 51% receiving PAP. Conclusion Patients treated with HNS therapy had significantly greater improvements in daytime sleepiness compared to PAP therapy, while the mean reduction of AHI and overall effectiveness were comparable for both treatments. Trial registration ClinicalTrial.gov Identifier: NCT03756805.
Evaluation of Hypoglossal Nerve Stimulation Treatment in Obstructive Sleep Apnea
JAMA Otolaryngology–Head & Neck Surgery
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.
Selective stimulation of the hypoglossal nerve: a FINE approach to treating obstructive sleep apnea
2002
Electrical activation of the tongue protrusor muscle has been demonstrated as an effective technique for alleviating upper airway (UAW) obstructions and is considered a potential treatment for obstructive sleep apnea (OSA). Recent studies, however, have shown marked improvements in UAW patency by coactivating the tongue protrudor and retractor muscles. As such, selective stimulation of the hypoglossal nerve (XII) using a single implantable device presents an attractive approach for treating OSA. In order to demonstrate the feasibility of such a device, the maximum achievable stimulation selectivity of the Flat Interface Nerve Electrode (FINE) was investigated. The XII nerve of beagles was stimulated with an acutely implanted FINE, while the corresponding neural and muscular responses were recorded and analyzed. The overall performance of the FINE, as depicted by the average of the maximum target-specific selectivity values, S(i), confirmed that high degrees of selectivity can be achieved at both the fascicular and muscular levels: 0.93 ± 0.03 (n = 5) and 0.88 ± 0.03 (n = 4), respectively. The results of this study demonstrate the feasibility of the FINE for selective stimulation of the XII nerve branches and the innervated tongue muscles.
Current Sleep Medicine Reports, 2017
Purpose-The literature on hypoglossal nerve stimulation (HNS) for the treatment of moderateto-severe obstructive sleep apnea (OSA) was reviewed from 2014, the time of FDA approval for the Inspire Systems device, to 2017 for themes that might be useful conceptually and practically in the consideration of this new non-anatomic surgical therapy. Recent Findings-there are now further follow-up articles since the 12-month results for Apnea Reduction (STAR) trial of the Inspire device, and post-approval publications which report similar and/0r improved AHI outcomes. Other emerging themes include drug-induced sedation endoscopy (DISE) as a tool in assessment of eligibility and a more detailed understanding of mechanisms for an HNS effects. Summary-The post-STAR literature provides guidelines for an integrated coordination of medicine and surgery to appropriately screen and manage patients.
Respiratory Investigation, 2016
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.