Airway Stimulation Research Articles

Home sleep apnea testing with peripheral arterial tonometry to assess outcome in upper airway stimulation.

To determine whether home sleep apnea testing with peripheral arterial tonometry (HSAT-PAT) can be used in upper airway stimulation to evaluate therapy success. Data analysis from 50 consecutive patients receiving upper airway stimulation was performed. Baseline values were measured by polysomnography and HSAT-PAT. Follow-up was performed during and after titration (3-6 months) by polysomnography and HSAT-PAT and after 1 year by HSAT-PAT only. Primary outcome measures were reduction in the apnea-hypopnea index and oxygen desaturation index. In addition, an analysis of night-to-night variability for HSAT-PAT was performed. All 50 patients completed their posttitration visit (3-6 months) and 41 patients completed the 1-year follow-up. In HSAT-PAT after 1 year, the mean apnea-hypopnea index (desaturation 3%) was reduced from 29.5 ± 17.1 events/h to 19.9 ± 13.1 events/h (P < .01) and the oxygen desaturation index (desaturation 4%) was reduced from 17.8 ± 12.6 events/h to 10.2 ± 8.3 events/h (P < .01). Therapy adherence after 1 year was high (6.6 ± 1.9 hours per night) and led to improvement in daytime sleepiness, meaning a reduction in the Epworth Sleepiness Scale score from 12.8 ± 5.4 to 5.9 ± 4.0 (P < .01). Analysis of night-to-night variability showed similar apnea-hypopnea index values between the 2 nights. Upper airway stimulation was able to reduce the apnea-hypopnea index and oxygen desaturation index after 1 year, as assessed by full-night efficacy studies with HSAT-PAT. In addition, improvements in self-reported outcome parameters were observed. The importance of publishing the scoring criteria is highlighted and whether data are based on full-night efficacy studies or a selected period of time from a sleep study. This is a prerequisite for comparing data with other trials in the emerging field of upper airway stimulation. Hinder D, Schams SC, Knaus C, Tschopp K. Home sleep apnea testing with peripheral arterial tonometry to assess outcome in upper airway stimulation. J Clin Sleep Med. 2022;18(9):2197-2205.

Does race-ethnicity affect upper airway stimulation adherence and treatment outcome of obstructive sleep apnea?

Untreated obstructive sleep apnea (OSA) is associated with excessive daytime sleepiness, decreased quality of life, and cardiovascular disease. Positive airway pressure is the first-line therapy for OSA; however, adherence is difficult. Upper airway stimulation is a Food and Drug Administration-approved treatment of OSA. The objective of this study was to evaluate for a difference in treatment efficacy and adherence of upper airway stimulation therapy for OSA between individuals who are White and non-White using data from the ADHERE registry. ADHERE registry is a multicenter prospective study of real-world experience of upper airway stimulation for treatment of OSA in the United States and Europe. Propensity score matching was used to create a balanced dataset between the White and non-White groups. t-Tests at a significance level of 5% were used to compare numeric values between groups. There were 2,755 participants of the ADHERE registry: 27 were excluded due to not having a race identified, 125 participants identified as non-White, 2,603 identify as White, and 27 did not provide race information. Propensity score matching was used to select 110 participants, with 55 White and 55 non-White for the noninferiority analysis. We did not find a difference in adherence, treatment apnea-hypopnea index, changes in Epworth Sleepiness Scale score, or clinical global impression after intervention score between White and non-White individuals. Our study found that there was no statistically significant difference in adherence or efficacy with upper airway stimulation therapy between White and non-White individuals. However, the percent of non-White people implanted is low, which suggests a need to expand access to this therapy for non-White populations with OSA who cannot tolerate positive airway pressure therapy. Khan M, Stone A, Soose RJ, etal. Does race-ethnicity affect upper airway stimulation adherence and treatment outcome of obstructive sleep apnea? J Clin Sleep Med. 2022;18(9):2167-2172.

Insomnia and Upper Airway Stimulation Therapy Benefit and Adherence: A Case Series.

Obstructive sleep apnea (OSA) and insomnia are common sleep disorders that often occur concurrently. The presence of one of these disorders often negatively impacts the other, including affecting treatment benefit and adherence. While insomnia has been shown to adversely affect positive airway pressure therapy adherence, minimal data are currently available on the effects of insomnia on upper airway stimulation (UAS) therapy for the treatment of OSA. We present two cases that highlight the negative impact of insomnia on UAS therapy usage and OSA management as well as the benefits of insomnia treatment on overall outcomes. Screening for and treatment of insomnia prior to UAS implantation are recommended.

0755 Comparison of clinical pathways for upper airway stimulation management: in-laboratory titration polysomnography versus home-based efficacy sleep testing

Abstract Introduction Upper airway stimulation (UAS) therapy is an alternative treatment option for select CPAP-intolerant patients with obstructive sleep apnea. Current standard-of-care management uses in-laboratory polysomnography for titration of UAS stimulation amplitude (tPSG) after 3 months of patient self-titration at home. This home monitoring study was designed to evaluate whether tPSG or efficacy home sleep test (eHST) with tPSG by exception for eHST non-responders would have non-inferior apnea-hypopnea index (AHI) outcomes. Methods Enrolled patients underwent UAS implantation as part of regular clinical care and were randomized at the activation visit 1:1 between tPSG or eHST for the 3-month post-activation visit. If eHST results were suboptimal (AHI &amp;gt; 15 events/h or &amp;lt; 50% reduction from baseline AHI) patients underwent tPSG titration at 5 months. Both groups had 2-night eHSTs at 6 months post-activation. The primary endpoint was 6-month AHI equivalence between arms (defined as ± 15 events/h). Secondary endpoints were equivalence of Epworth Sleepiness Score (ESS; ± 2), oxygen desaturation index (ODI; ± 15 events/h), and nightly UAS device usage (± 0.5 h). Results The study randomized 60 patients from August 2020 through September 2021, who were primarily middle aged (57 ± 10 years), male (67%), Caucasian (98%), and overweight (BMI 29 ± 3 kg/m2), with severe OSA (AHI 35 ± 16). Eleven patients withdrew from the study early. As of December 2021, 41 and 36 patients have completed 3- and 6-month follow-up visits, respectively. Six-month visit AHI, ESS, ODI, and device usage data between arms is currently blinded and is expected to be complete by Q2 2021 prior to SLEEP 2022. Conclusion If the study demonstrates equivalent 6-month AHI, ESS, ODI, and usage outcomes, the use of eHST to ascertain therapy efficacy prior to tPSG could be a non-inferior alternative management option to tPSG. Support (If Any) Sponsored by Inspire Medical Systems, Inc.

0749 Does Prior Nasal Surgery Impact Outcomes of Upper Airway Stimulation Therapy for OSA?

Abstract Introduction Nasal airway obstruction can play an important role in pathogenesis and treatment of obstructive sleep apnea (OSA). Surgery for nasal obstruction can improve patient-reported OSA outcomes, including snoring and daytime sleepiness, as well as adherence and pressure requirements with continuous positive airway pressure (CPAP) therapy. The aim of this study was to examine whether previous nasal surgery was associated with UAS treatment efficacy. Methods From the ADHERE Registry, propensity score matching generated a cohort of UAS patients with prior nasal surgery including septoplasty, turbinate reduction, polyp removal (NS) and a comparable cohort of UAS patients without prior nasal surgery (WNS). Patients were matched based on demographic variables including pre-operative oral appliance use, prior CPAP use, gender, age, baseline apnea hypopnea index (AHI) and baseline Epworth Sleepiness Score (ESS). Data included demographic variables, therapy outcome measures including AHI, ESS, therapy use, and responder rate. Student’s t-test was used to compare normally distributed numeric data and Fisher’s exact test to compare categorical data. One sided t-tests with non-inferiority margin of 7.5 events/hr for AHI, 2 points for ESS, and 0.5 hr/night for Therapy Use were performed to determine non-inferiority. Results The ADHERE dataset from October 2021 included 169 patients from each cohort were matched for comparison. Reduction in AHI was 21.01 ±17.94 in WNS cohort and 18.39 ± 16.4 after UAS (p=0.162) in NS cohort. Reduction in ESS in WNS cohort was 4.85 ± 4.98 and 4.48 ±5.83 (p=0.528) in NS cohort. Therapy use was similar, 5.67 ± 1.95 in WNS and 5.97 ± 2.06 in NS (p=0.181). Responder rate was also similar in WNS (64.5%) and NS (62.1%) (p=0.735). Conclusion Retrospective analysis of UAS patients with vs without prior nasal surgery did not identify differences in UAS therapy outcomes or adherence. Furthermore, outcomes for patients with nasal surgery were non-inferior to those without. Future prospective studies of UAS candidates with nasal airway obstruction may better determine the role of adjunctive nasal surgery in this population. Support (If Any) Inspire Medical Systems

0775 Impact of insomnia, depression and anxiety on adherence to upper airway stimulation for obstructive sleep apnea: ADHERE registry update

Abstract Introduction Insomnia, depression and anxiety are common comorbid conditions in patients with obstructive sleep apnea (OSA) and can negatively impact positive airway pressure (PAP) therapy adherence. Subsequent intolerance to PAP may lead to surgical treatment such as upper airway stimulation (UAS). We sought to determine the impact of baseline insomnia, anxiety or depression on UAS therapy adherence using data from a large multi-center registry. Methods The ADHERE registry collects information on patients undergoing UAS (Inspire Medical, Golden Valley, MN) including baseline history of insomnia, depression, anxiety and the Insomnia Severity Index (ISI) questionnaire. We determined overall prevalence of insomnia, depression and/or anxiety, as well as UAS adherence after 6 months of therapy in groups with insomnia, depression, anxiety or none of these conditions. Using ISI to quantify insomnia, adherence in patients with no/mild insomnia (ISI &amp;lt; 15) was compared to those with moderate/severe insomnia (ISI ≥ 15). Results 1639 patients were included; 10% reported a history of insomnia, 23% depression and 16% anxiety. There was no difference in UAS adherence between groups with or without a history of insomnia, depression, or anxiety. A baseline ISI score was available in 470 patients with no history of insomnia, and in 81 patients with a history of insomnia. In patients with no history of insomnia, 59% had ISI scores ≥15, while in those with a history of insomnia, 85% had ISI scores ≥15 (p &amp;lt; 0.001). There was no difference in therapy usage between patients with ISI scores &amp;lt;15 and ≥15 (6.7 ± 2.2 hours/night versus 6.4 ± 2.5 hours/night, p = 0.5). Conclusion This study examined the impact of insomnia, depression or anxiety on adherence to UAS therapy for OSA. Patients with and without these conditions had similar UAS adherence. We found that insomnia as objectively based on the ISI score may be underdiagnosed in UAS patients who have no subjective history of insomnia at baseline. Despite this, ISI severity did not impact UAS adherence. Longer term follow-up with serial ISI scores and adherence data is needed to further understand how insomnia severity impacts UAS therapy outcomes and usage. Support (If Any)

0772 Clusters of Upper Airway Stimulation Adherence Patterns in the First 90 Days

Abstract Introduction Upper airway stimulation (UAS) therapy is effective for a subset of obstructive sleep apnea (OSA) patients with CPAP intolerance. While overall adherence is high, some patients have suboptimal adherence to UAS, which limits effectiveness. Our goal was to identify UAS therapy usage patterns during the first three months of therapy that affect adherence. Methods We retrieved anonymized UAS therapy usage data from 2,091 individuals stored in a cloud-based monitoring system during the first three months after device activation. We aggregated adherence data including mean and standard deviation (SD) of nightly hours of use, therapy pauses, hours from midnight when the therapy was turned ON and OFF, and percentage of missing days. We computed the difference of the stimulation amplitude between the first and last day. We performed cluster analysis with Gaussian mixture models and computed the centroids of each cluster highlighting their main differences. Results We identified six distinct clusters of UAS usage patterns. Clusters 1A (34% of the total cohort) and 1B (23%) had excellent therapy usage with 7.23h and 7.14h on days of use, respectively; with 1B distinguished by increased night-to-night variability. Clusters 2A (16%) and 2B (12%) had good mean therapy use of 6.63h and 6.21h, respectively, but their usage patterns were distinguished by a higher percentage of missing days (8% missing days in 2A and 23% in 2B) and less favorable therapy timing with an average therapy ON time after midnight. Clusters 3A (8%) and 3B (7%) were characterized by the lowest nightly use at 6.16h and 5.50h, respectively, and the highest night-to-night variability. 3A was further distinguished by the highest percentage of missing days (34%) while 3B was characterized by the frequent therapy pauses (mean 4.1 pauses per night) and the least increase in stimulation amplitude across the first 90 days. Conclusion Cluster analysis of UAS usage patterns identified six distinct groups that may enable custom interventions for improved long-term management. Differentiation of these groups may have clinical implications on conditions (e.g. therapy discomfort, comorbid insomnia, poor sleep hygiene) that impact adherence. Support (If Any)

0333 Gender and Menopausal Status Correlate with Sleep Surgery Outcome

Abstract Introduction With recognized anatomic and physiological differences between males and females, it is critical to describe outcomes of sleep surgery with respect to gender. The objective of this study is to compare the subjective and objective outcomes of phase I sleep surgery with respect to gender and age. Methods This was a retrospective review of adult subjects who presented to a single center for surgical evaluation of OSA from January 2019 to June 2021. Only subjects undergoing phase I surgery (turbinate reduction, septoplasty, nasal valve surgery, DOME, tonsillectomy, preservation palatopharyngoplasty, tongue base reduction, genioglossus advancement, and upper airway stimulation), who also had complete pre and post-operative PSG data were included. Objective measures were post operative apnea hypopnea index (AHI), oxygen desaturation index (ODI), and lowest oxygen saturations (LOS). Subjective outcomes include Epworth Sleepiness Scale (ESS), and Nasal Obstruction and Septoplasty Effectiveness (NOSE) questionnaires. The groups were matched for age and pre-operative BMI. Results Twenty-six subjects met inclusion criteria, of which 12 were female and 13 were males. Of the females 5 were post-menopausal. The average male pre-operative AHI, ODI, lowest SpO2, and ESS were 34.4± 28.7, 30.2±28.3, 80.7±6.6, and 10.3±5.6 respectively. Pre-operative values for females were, 31.9±19.2, 18.47±20.4, 82.8±8.4, and 12.5±4.8 respectively. The average AHI reduction in males was 25.5± 29.1, and for females it was 8.3±21.0 (p=0.042). Specific to post-menopausal females, Average AHI reduction was 8.3± 21.0 and 20.2±16.6 for pre-menopausal females (p=0.01). The average ESS reduction in males was 3.1±3.2 (p=0.22) and for females 5.5±5.4 (p=0.001). Conclusion In this cohort, pre-menopausal women have higher objective surgical success rate (Sher’s criteria) after phase I surgery as compared to post-menopausal women. Men respond more favorably than women to phase I surgery based on AHI reduction, but not with ESS. Gender and menopause status are important factors in evaluating efficacy of sleep surgery. Support (If Any)

0768 A Million Dreams: Improving Compliance and Treatment of Obstructive Sleep Apnea via Upper Airway Stimulation Therapy. Real-World Outcomes

Abstract Introduction Patient compliance to continuous positive airway pressure (CPAP) has been about 50% at 4-years despite numerous improvements in mask design, flow algorithms, education, and monitoring software. Compliance, however, is not equivalent to efficacy. Upper Airway Stimulation (UAS) is an alternative for select CPAP intolerant patients. We used a patient management platform to track UAS compliance and efficacy. Methods Anonymized, aggregated device usage and outcomes data was analyzed from a HIPAA compliant patient management platform (Inspire Cloud, Inspire Medical Systems, Golden Valley MN) through October 2021. Demographic data is not collected. We used this database to understand therapy outcomes. Data are presented as mean and standard deviation, unless otherwise noted. Results There were 1.74 million usage nights for 5,709 patients across 550 clinics. Patients increased median stimulation amplitude from 1.4 to 2.2 volts between activation to 90 days after activation. Typical therapy was activated at 11:44pm, and turned off at 5:51am, with one 13-minute pause per night, and therapy was on 89% of nights.Usage was 5.5 ± 1.8 hours per nights overall, and 6.0 ± 1.9 hours per night used. At 90 days, 90% of patients had usage &amp;gt; 4 hours per nights overall, and 96% had usage &amp;gt; 4 hours per night used.Average pre-implant AHI was reduced from 35 ± 15 events/hour (n=2760), to 9 ± 12 (n=1609) after therapy. ESS was reduced from 11 ± 5 (n=1254) to 7 ± 5 (n=1164). Conclusion This data represents the first big-data reporting of UAS therapy usage in general clinical practice including nightly data. It demonstrates high nightly usage with minimal pauses and marked improvement in symptoms. It demonstrates the potential that CPAP intolerant patients with can be fully adherent with alternative therapy. Support (If Any) Statistical support provided by Inspire Medical systems.

0764 Evaluation of cloud-connected home sensors of apnea-hypopnea index versus polysomnography and home sleep test during upper airway stimulation home titration

Abstract Introduction A growing number of cloud-connected sensors can longitudinally record apnea hypopnea index (AHI) at home. The Ectosense NightOwl is an FDA-approved peripheral arterial tomography device; the Withings Sleep Analyzer mat is an under-mattress sensor with AHI data for retrospective research use (CE marked, not FDA approved). We used these sensors to monitor patients with upper airway stimulation (UAS) therapy during therapy acclimatization and post-titration follow-up and compared sensor AHI to polysomnography (PSG) and home sleep test (HST) AHIs. Methods Enrolled patients underwent UAS implantation as part of regular clinical care and were required to have a smartphone. The Ectosense and Withings sensors were distributed at UAS device activation. Patients were asked to use NightOwl weekly, and Withings provided nightly AHI. Sleep studies (PSG &amp; HST) occurred at 3 and 6-mo post implant. Ectosense &amp; Withings AHI were averaged and correlated against the nearest 3- and 6-month sleep study AHIs. Results Patients were 67% male, aged 57 ± 10 years. Smartphone platforms were 59% Apple iOS, 24% Google Android, and 17% Unknown. As of October 2021, 45 patients have had near-simultaneous Withings and PSG/HST AHI, 35 have had near-simultaneous NightOwl and PSG/HST AHI. The Withings AHI was fairly linear against PSG/HST AHI, adjusted R2 = 0.47, p &amp;lt; 0.0001, (y=10 + 0.82x). Withings AHI &amp;lt; 15 (n=18) had a 90% positive predictive value for a PSG/HST AHI less than 15 (n=20). Ectosense data was less linear and more scattered, adjusted R2 = 0.15, p=0.01, (y=14 + 0.47x). Ectosense AHI &amp;lt; 15 (n=12) had an 80% positive predictive value of a PSG/HST AHI less than 15 (n=15). Conclusion Home-based sensors provide longitudinal SDB data in a home setting and may adequately classify patients with mild sleep apnea, and may have utility for home-based management of UAS patients in the post-implantation period. Support (If Any) Inspire Medical Systems

Evaluation of Upper Airway Stimulation for Adolescents With Down Syndrome and Obstructive Sleep Apnea

Patients with Down syndrome have a high incidence of persistent obstructive sleep apnea (OSA) and limited treatment options. Upper airway hypoglossal stimulation has been shown to be effective for adults with OSA but has not yet been evaluated for pediatric populations. To evaluate the safety and effectiveness of upper airway stimulation for adolescent patients with Down syndrome and severe OSA. This prospective single-group multicenter cohort study with 1-year follow-up was conducted between April 1, 2015, and July 31, 2021, among a referred sample of 42 consecutive adolescent patients with Down syndrome and persistent severe OSA after adenotonsillectomy. Upper airway stimulation. The prespecified primary outcomes were safety and the change in apnea-hypopnea index (AHI) from baseline to 12 months postoperatively. Polysomnographic and quality of life outcomes were assessed at 1, 2, 6, and 12 months postoperatively. Among the 42 patients (28 male patients [66.7%]; mean [SD] age, 15.1 [3.0] years), there was a mean (SD) decrease in AHI of 12.9 (13.2) events/h (95% CI, -17.0 to -8.7 events/h). With the use of a therapy response definition of a 50% decrease in AHI, the 12-month response rate was 65.9% (27 of 41), and 73.2% of patients (30 of 41) had a 12-month AHI of less than 10 events/h. The most common complication was temporary tongue or oral discomfort, which occurred in 5 patients (11.9%). The reoperation rate was 4.8% (n = 2). The mean (SD) improvement in the OSA-18 total score was 34.8 (20.3) (95% CI, -42.1 to -27.5), and the mean (SD) improvement in the Epworth Sleepiness Scale score was 5.1 (6.9) (95% CI, -7.4 to -2.8). The mean (SD) duration of nightly therapy was 9.0 (1.8) hours, with 40 patients (95.2%) using the device at least 4 hours a night. Upper airway stimulation was able to be safely performed for 42 adolescents who had Down syndrome and persistent severe OSA after adenotonsillectomy with positive airway pressure intolerance. There was an acceptable adverse event profile with high rates of therapy response and quality of life improvement. ClinicalTrials.gov Identifier: NCT02344108.

Upper Airway Stimulation for Children With Down Syndrome and Obstructive Sleep Apnea—A New Frontier

Upper Airway Stimulation for Children With Down Syndrome and Obstructive Sleep Apnea—A New Frontier

Cluster analysis of upper airway stimulation adherence patterns and implications on clinical care

Upper airway stimulation (UAS) therapy is effective for a subset of obstructive sleep apnea (OSA) patients with continuous positive airway pressure (CPAP) intolerance. While overall adherence is high, some patients have suboptimal adherence, which limits efficacy. Our goal was to identify therapy usage patterns during the first 3 months of therapy to enable targeted strategies for improved adherence. Therapy data was retrieved from 2098 patients for three months after device activation. Data included mean and standard deviation (SD) of hours of use, therapy pauses, hours from midnight the therapy was turned ON and OFF, percentage of missing days, and stimulation amplitude. Cluster analysis was performed using Gaussian mixture models that categorized patients into six main groups. The six groups and their prevalence can be summarized as Cluster 1A: Excellent Use (34%); Cluster 1B: Excellent Use with variable timing (23%); Cluster 2A: Good Use with missing days and late therapy ON (16%), Cluster 2B: Good Use with missing days, late therapy ON, and early therapy OFF (12%); Cluster 3A: Variable Use with frequent missing days (8%); Cluster 3B: Variable Use with frequent pauses (7%). Most patients (85%) are excellent or good users with mean therapy use >6 hours per night. Cluster analysis of early UAS usage patterns identified six distinct groups that may enable personalized interventions for improved long-term management. Differentiation of the patient clusters may have clinical implications with regard to sleep hygiene education, therapy discomfort, comorbid insomnia, and other conditions that impact adherence.

Similar effect of hypoglossal nerve stimulation for obstructive sleep apnea in 5 disease severity categories.

Data on adherence and outcome of upper airway stimulation (UAS) for patients with obstructive sleep apnea (OSA) are collected in an international registry (ADHERE). Previous publications report significant improvement in self-reported and objective OSA outcomes, durable effectiveness, and high adherence. Debate remains whether the effectiveness of UAS is influenced by preoperative OSA severity; therefore, we aimed to evaluate this using data from the ADHERE Registry. ADHERE is a postmarket, ongoing, international multicenter registry. Adult patients were included if they had undergone UAS implantation and had at least 1 follow-up visit recorded in the database on June 8, 2021. We divided the patients into 5 subgroups, based on OSA severity at baseline (AHI in events/h): subgroup 1 (0-15), 2 (15-30), 3 (≥ 30-50), 4 (> 50-65), and 5 (> 65). We compared results regarding objective and self-reported treatment outcomes. A total of 1,963 patients were included. Twelve months after implantation, there was a significant (P < .0001) improvement in objective sleep parameters in all subgroups with an AHI above 15 events/h. Patients in subgroup 1 had the lowest AHI at the final visit and the AHI reduction in patients in subgroup 5 was the largest (P < .0001). No significant difference was found between the subgroups in overall treatment success (66.6%) and improvement in self-reported outcomes. Our results suggest that UAS is an effective treatment for patients with an AHI ≥ 15 events/h, independent of preoperative OSA severity. Self-reported outcomes and treatment success did not differ significantly between the 5 subgroups. These results clearly support that the indication of UAS could be broadened for patients with an AHI above 65 events/h, which, to date, is not common practice. Registry: ClinicalTrials.gov; Title: Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry (ADHERE Registry); Identifier: NCT02907398; URL: https://www.clinicaltrials.gov/ct2/show/NCT02907398. Bosschieter PFN, de Vries N, Mehra R, etal. Similar effect of hypoglossal nerve stimulation for obstructive sleep apnea in 5 disease severity categories. J Clin Sleep Med. 2022;18(6):1657-1665.

Respiratory adverse events associated with deep propofol sedation during upper gastrointestinal procedures in children

Background/Aims: Upper airway stimulation with endoscopes and pH-impedance probes during deep propofol sedation confers unknown risk for associated respiratory adverse airway events. This report quantifies frequencies of such events and airway rescue interventions associated with Esophagogastroduodenoscopies (EGD) and multi-channel intraluminal acid detection impedance probe (MIIP) placements. Methods: This was a prospective observational study regarding occurrence of adverse respiratory events in 42 children undergoing propofol sedated EGDs and MIIP placements: Group 1. (n=21 EGDs), Group2 (n=21 EGDs before MIIP), Group 3. (n=21 during MIIP). Results: All procedures were successfully completed using deep propofol sedation. Respiratory events were transient and associated with no morbidity or mortality. Nearly half of each group experienced a respiratory event. “Partial airway obstruction” during 42 EGDs occurred in 28.6% and responded to simple airway interventions. “Complete airway obstruction” occurred during 1/42 EGDs and 2/21 MIIPs. Throughout MIIP placement, endoscopic visualization of the glottis was maintained and unnecessary stimulation of the glottis was avoided; nonetheless, complete airway obstruction occurred in 2/21. Advanced airway rescue maneuvers were not required in either instance. Conclusions: Respiratory adverse events commonly occurred during EGDs and MIIP placements. All events were successfully rescued by simple airway interventions.

Variable negative external pressure-an alternative to continuous positive airway pressure for the treatment of obstructive sleep apnea: a pilot study.

To assess variable negative external pressure (vNEP) therapy using a range of pressures and varying collar sizes and shapes to identify combinations that improve the efficacy and comfort of this emerging therapy for obstructive sleep apnea (OSA). This prospective, open-label pilot study included 28 eligible patients (71% men) having documented moderate OSA (apnea-hypopnea index [AHI] 15 events/h ≤ AHI ≤ 30 events/h) at 1 sleep clinic for an overnight, in-lab sleep trial. Each participant tested at least 2 of 6 available vNEP devices during sleep periods ≥ 2 hours. During the assessment of AHI by polysomnography, negative pressures of -20 cm H2O to -35 cm H2O were adjusted to improve each patient's response. Participants' therapeutic preferences were assessed by a questionnaire and interviews. Twenty (71%) of the participants responded to vNEP therapy: excellent response (AHI ≤ 5 events/h) was observed in 14 (50%); 6 (21%) achieved a partial response (AHI ≤ 50% baseline). For the 20 responders, the therapy reduced the fraction of total sleep time when peripheral oxygen saturation < 90% and improved minimum pulse oximetry oxygen saturation. Six patients experienced a minor, self-limited adverse event. Twenty-six participants (93%) stated that they would use vNEP nightly. In this pilot study, vNEP therapy markedly improved AHI and oxygenation in most patients with moderate OSA. The majority of participants found vNEP comfortable and preferable to prevailing OSA therapies. Further development and studies of vNEP are warranted. Registry: ClinicalTrials.gov; Name: Study of Variable Negative External Pressure (vNEP) in Reducing Respiratory Event in Individuals With OSA; URL: https://clinicaltrials.gov/ct2/show/NCT04718142; Identifier: NCT04718142. Kram JA, Pelayo R. Variable negative external pressure-An alternative to continuous positive airway pressure for the treatment of obstructive sleep apnea: A pilot study. J Clin Sleep Med. 2022;18(1):305-314.

Comparative Efficacy of Patients with OSA Undergoing Multi-level Surgery followed by Upper Airway Stimulation vs. Isolated Upper Airway Stimulation

PurposeUpper airway stimulation (UAS) via hypoglossal nerve stimulation is a viable management option for patients with obstructive sleep apnea (OSA). Important exclusion criteria for the current UAS protocol include AHI above 65 events per hour or concentric collapse of the velum seen on drug-induced sedation endoscopy (DISE). The authors describe the treatment efficacy of a cohort of UAS patients who were initially ineligible, but who were implanted following multilevel surgery that reversed the exclusion criteria. MethodsThe design in a single-center, retrospective study. Data collection included demographics, body-mass index (BMI), apnea-hypopnea index (AHI) titration results, oxygen desaturation index (ODI), Drug Induced Sedation Endoscopy (DISE) results, Epworth sleepiness score (ESS), and Fatigue Severity Score (FSS). ResultsThirty-six subjects underwent UAS implantation (Inspire system, MN, USA) from 2016 to 2019. Eighteen subjects who were initially ineligible for UAS first underwent multi-level surgery, including uvulopalatopharyngoplasty (UPPP), genioglossus advancement (GGA), distraction osteogenesis maxillary expansion (DOME), or maxillomandibular advancement (MMA). Mean subject age was 62.3±9 years with 28% being female. Mean subject BMI was 29±4kg/m2. Seventeen subjects met the criteria for UAS and underwent surgery. Mean subject age was 62.9±14 years with 12% being female. Mean subject BMI was 26.7±4kg/m2. Mean pre-treatment AHI for 2-staged patients was 49±29 events per hour, which was reduced to 3.6±5 events per hour with an average voltage of 1.8V±0.9. Mean pre-treatment AHI for UAS-only cohort was reduced from 33±14 events per hour to 5.3±6 events per hour with an average voltage of 1.9V±0.3. ConclusionFor patients who are ineligible for UAS due to severity of OSA or concentric collapse of the velum, multilevel surgery including UPPP, GGA, DOME, or MMA followed by UAS confers reliable, effective, and equitable post-treatment results.

Post-operative Complication Rate Comparison Between Airway Surgery and Upper Airway Stimulation Using NSQIP and ADHERE.

ObjectivePostoperative complication rates were compared between obstructive sleep apnea surgery (OSAS) and hypoglossal nerve upper airway stimulation (UAS).Study DesignCohort.SettingMulti-institutional international databases.MethodsOSAS data were collected from the NSQIP database (2014; American College of Surgeons National Surgery Quality Improvement Program). UAS data were obtained from the ADHERE registry (Adherence and Outcome of Upper Airway Stimulation for OSA International Registry; 2016–December 2019). ADHERE comorbidities and complications were categorized to match NSQIP definitions. A chi-square test was used for proportion P values.ResultsThere were 1623 UAS procedures in ADHERE and 310 in NSQIP. The UAS group was older than the OSAS group (mean ± SD, 60 ± 11 vs 42 ± 13 years) but similarly male (75% vs 77%) and overweight (body mass index, 29 ± 4 vs 29 ± 3 kg/m2). There was a higher proportion of hypertension, diabetes, and heart disease in the UAS cohort. Palatopharyngoplasty was the most common surgical procedure (71%), followed by tonsillectomy (25%). UAS operative time was longer (132 ± 47 vs 54 ± 33 minutes). Postoperative length of stay was not normally distributed, as 71% of UAS stays were <1 day as opposed to 40% of OSA stays (P < .0001). Thirty-day return to the operating room related to the procedure was 0.1% for UAS and 4.8% for OSAS (P < .0001). Surgical site infections were 0.13% for UAS and 0.9% for OSAS (P = .046).ConclusionThe UAS cohort was older and more likely to have comorbid hypertension, diabetes, and heart disease. Despite baseline differences, the postoperative complication rate was lower with UAS than with OSAS.

Hypoglossal Nerve Stimulation Usage by Therapy Nonresponders.

The purpose of this study is to examine differences in therapy usage and outcomes of therapy between responder (R) and nonresponder (NR) groups in an international, multicenter prospective registry of patients undergoing hypoglossal nerve stimulation for obstructive sleep apnea (OSA). Database analysis (level III). International, multicenter registry. The studied registry prospectively collects data pre- and postimplantation, including sleep parameters, Epworth score, patient experience, and safety questions, over the course of 12 months. Patients are defined as a "responder" based on Sher criteria, which require a final apnea-hypopnea index (AHI) of ≤20 and a final AHI reduction of >50% at their 12-month follow-up. Overall, there were 497 (69%) R and 220 (31%) NR. Most patients in both groups experienced improvement in quality of life following implantation (96% of R; 77% of NR) with reductions in oxygen desaturation index and Epworth score. At final follow-up, the R group demonstrated significantly better adherence to recommended therapy (>4 hours/night) (P = .001), average hours of nightly use (P = .001), final Epworth scores (P = .001), and degree of subjective improvement (P < .001). Patients classified as NR to upper airway stimulation continue to use therapy with improvement in percent time of sleep with O2 <90%, reduction in daytime sleepiness, and improvement in quality of life. Therefore, ongoing usage of the device should be encouraged in NR patients who note improvement while integrating additional strategies to lower the long-term effects of OSA.

Evaluating YouTube Videos on Hypoglossal Nerve Stimulation as a Resource for Patients.

This study evaluated the quality and comprehensiveness of YouTube videos on hypoglossal nerve stimulation (HNS) for patients. This study also investigated the relationship between video content, video metrics, and popularity. Cross-sectional study. We identified 150 videos using three search terms: "inspire sleep apnea," "hypoglossal nerve stimulation," and "upper airway stimulation." Videos that were unrelated to the use of HNS for obstructive sleep apnea in adults, operating room recordings, lectures for medical professionals, non-English, or non-audio were excluded. Video quality and comprehensiveness were assessed using modified DISCERN criterion (range: 5-25) and novel content criterion (range: 0-12), respectively. Secondary outcomes included video metrics (views, likes, dislikes, comments, and days since upload) and Video Power Index to measure popularity. Outcomes were stratified by video uploader source (medical institutions, medical companies, individual users, other). Users searched YouTube for "inspire sleep apnea" 2.48 times more in 2020 than in 2018. We identified 67 videos for review, with the majority coming from medical institutions (70.2%). Overall, the average-modified DISCERN (13.65 ± 4.88) and novel content (3.87 ± 2.09) scores were low and did not differ between medical institutions or other uploader sources. Higher quality and more comprehensive video content did not correlate with popularity. Overall quality and comprehensiveness of information of HNS YouTube videos was low. Given the high demand for information on HNS, there is opportunity for medical institutions to implement new strategies to improve both video content and visibility to patients. NA Laryngoscope, 131:E2827-E2832, 2021.