A Noninferiority Analysis of 3- vs 2-Incision Techniques for Hypoglossal Nerve Stimulator Implantation

2021 ◽  
pp. 019459982110621
Author(s):  
David T. Kent ◽  
Eugene G. Chio ◽  
Jordan S. Weiner ◽  
Clemens Heiser ◽  
Maria V. Suurna ◽  
...  

Objective The only hypoglossal nerve stimulation (HNS) device available for US clinical use is implanted through 3 incisions. A recently proposed 2-incision modification moved the respiratory sensing lead from the fifth to the second intercostal space to eliminate the third lower chest incision. This study compared perioperative data and therapeutic outcomes between the techniques. Study Design Noninferiority cohort analysis of a retrospective and prospective registry study. Setting Tertiary care and community surgical centers. Methods Patients with obstructive sleep apnea underwent HNS implantation via a modified 2-incision technique (I2). A cohort previously implanted via the standard 3-incision technique (I3) were 1:1 propensity score matched for a noninferiority analysis of postoperative outcomes. Results There were 404 I3 patients and 223 I2 patients across 6 participating centers. Operative time decreased from 128.7 minutes (95% CI, 124.5-132.9) in I3 patients to 86.6 minutes (95% CI, 83.7-97.6) in I2 patients ( P < .001). Postoperative sleep study data were available for 76 I2 patients who were matched to I3 patients. The change in apnea-hypopnea index between the cohorts was statistically noninferior (a priori noninferiority margin: 7.5 events/h; mean difference, 1.51 [97.5% CI upper bound, 5.86]). There were no significant differences between the cohorts for baseline characteristics, perioperative adverse event rates, or change in Epworth Sleepiness Score ( P > .05). Conclusion In a multicenter registry, a 2-incision implant technique for a commercially available HNS device had a statistically noninferior therapeutic efficacy profile when compared with the standard 3-incision approach. The 2-incision technique is safe and effective for HNS implantation.

2021 ◽  
pp. 019459982110234
Author(s):  
Phillip Huyett

Objective To examine the changes in measures of sleep apnea severity and hypoxemia on the first postoperative night following implantation of the hypoglossal nerve stimulator. Study Design This was a single-arm prospective cohort study. Setting A single academic sleep surgical practice. Methods Subjects with moderate to severe obstructive sleep apnea underwent implantation of the hypoglossal nerve stimulator (HGNS) and were discharged to home the same day as surgery. A single-night WatchPAT study was performed on the night immediately following surgery (PON 1) and was compared to baseline sleep testing. Results Twenty subjects who were an average of 58.6 ± 2.5 years old, were 25% female, and had a mean body mass index of 28.1 ± 0.9 kg/m2 completed the study. Mean O2 nadir at baseline was 79.6% ± 1.1% compared to 82.7% ± 0.9% ( P = .013) on PON 1. One patient demonstrated a >10% worsening in O2 nadir. Only 2 additional patients demonstrated a worsening in O2 nadir on PON 1, each by only 1 percentage point. Neither mean time spent below SpO2 88% nor oxygen desaturation index (ODI) worsened postoperatively (mean time spent below oxygen saturation of 88%, 27.8 ± 7.85 vs 11.2 ± 5.2, P = .03; mean ODI, 29.6 ± 5.2/h vs 21.0 ± 5.4/h, P = .10). Mean obstructive apnea hypopnea index (AHI) was no worse (40.6 ± 4.7/h to 28.7 ± 4.2/h, P = .02), with only 2 patients experiencing an obstructive AHI >20% more severe than baseline. Only 1 patient demonstrated a clinically meaningful increase in central AHI on PON 1. Conclusions Overall, AHI and measures of nocturnal hypoxemia are stable, if not improved, on PON 1 following HGNS implantation. These findings support the safety of same-day discharge following implantation of the hypoglossal nerve stimulator.


SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A438-A438
Author(s):  
O M Bubu ◽  
A D Turner ◽  
A Parekh ◽  
A Mullins ◽  
K Kam ◽  
...  

Abstract Introduction We examined race and sex-specific biologic mechanisms of the relationship between obstructive sleep apnea (OSA) and incident AD. Methods Retrospective cohort analysis utilizing in-lab PSG sleep study data conducted among older adults between 2001 and 2005. OSA was defined using AHI4%. Participants had no history of cognitive decline or AD at baseline and included 663 (284 Non-Hispanic White (NHW), 207 Black/African-American (AA) and 172 Hispanic) OSA-patients matched on age, sex, race, BMI, 1:1 ratio to 663 (unexposed cohort I from sleep clinic) and 1:4 ratio to 2652 (unexposed cohort II from non-sleep clinics) non-OSA individuals. Incident AD was assessed annually from 2001-2013 with ICD-9-CM code 331.0. Adjusted cox proportional hazard regression models examined race and sex-specific biologic mechanisms including hypoxia, fragmentation and duration measures of OSA and AD risk. Results Of the 3,978 participants, 2,148 (54%) were women. Mean age at baseline was 72.6 (7.3) years. Over a mean follow-up time of 8.6 (1.4) years, 358 (9%) individuals (212 female) developed AD (119 NHW, 134 AAs, and 105 Hispanics). Relative to non-OSA individuals, OSA-patients had a higher risk of incident AD, with AAs and females showing stronger risk estimates (aHR: 2.24, 1.83, and 1.73, P &lt;.001 for all, for AAs, Hispanics and NHW respectively; and aHR: 2.38, and 1.37, P &lt;.001 for all, for female and male respectively). Measures of hypoxia, sleep fragmentation and sleep duration were associated with increase AD risk (P &lt;.01 for all). Relative to NHW, AAs and Hispanics demonstrated up to 20% stronger effects/estimates on hypoxia and sleep duration measures. Relative to males, females demonstrated up to 25% stronger effects/estimates on sleep fragmentation measures, and 15% weaker effects/estimates on hypoxia measures (P &lt;.01 for all). Conclusion Among OSA-patients, mechanisms related to hypoxia, sleep fragmentation and duration measures increase AD risk and may underlie race/ethnicity and sex disparities in AD. Support NIH/NIA/NHLBI (L30-AG064670, CIRAD P30AG059303 Pilot, T32HL129953, R01HL118624, R21AG049348, R21AG055002, R01AG056031, R01AG022374, R21AG059179, R01AG056682, R01AG056531, K07AG05268503, K23HL125939)


2020 ◽  
pp. 105566562096405
Author(s):  
Nicholas Siegel ◽  
Joseph Lopez ◽  
Aria C. Shi ◽  
Sara Neimanis ◽  
Diana Jodeh ◽  
...  

Objective: Mandibular distraction osteogenesis (MDO) aims to relieve tongue-based airway obstruction in Robin Sequence (RS). We investigated direct laryngoscopy grade (DLG) improvement and difficult airway (DA) resolution following MDO. Design: Retrospective cohort analysis. Setting: Three tertiary care institutions. Patients: Sixty-four infants with RS who underwent a single MDO procedure in their first year of life were identified from January 2010 to January 2019. Main Outcome Measures: The primary outcome was DLG pre- and post-MDO. Secondary outcomes included DA designation, pre- and post-MDO polysomnographic assessment for obstructive sleep apnea (OSA), length of stay, need for gastrostomy, and major/minor adverse events. Results: Median DLG improved from II pre-MDO to I at the time of distractor removal (n = 43, P < .001). No significant change was seen in patients with a third recorded time point (eg, palatoplasty; n = 78, P = .52). Twenty-six (47%) of 55 patients were designated as DA pre-MDO, and 10 (18%) of 55 patients retained the label post-MDO ( P < .01). Five (50%) of these 10 patients appeared to be inappropriately retained. Median obstructive apnea–hypopnea index improved from 38.6 (range 31.2-62.8) pre-MDO to 2.9 (range 1-3.9) post-MDO (n = 12; P = .002). Conclusion: Mandibular distraction osteogenesis allowed for DLG improvement that was stably maintained as well as functional improvement in OSA, with minimal morbidity. Difficult airway designation persisted in the electronic record of some infants despite clinical resolution.


SLEEP ◽  
2019 ◽  
Vol 43 (6) ◽  
Author(s):  
Mudiaga Sowho ◽  
Francis Sgambati ◽  
Michelle Guzman ◽  
Hartmut Schneider ◽  
Alan Schwartz

Abstract Snoring is a highly prevalent condition associated with obstructive sleep apnea (OSA) and sleep disturbance in bed partners. Objective measurements of snoring in the community, however, are limited. The present study was designed to measure sound levels produced by self-reported habitual snorers in a single night. Snorers were excluded if they reported nocturnal gasping or had severe obesity (BMI &gt; 35 kg/m2). Sound was measured by a monitor mounted 65 cm over the head of the bed on an overnight sleep study. Snoring was defined as sound ≥40 dB(A) during flow limited inspirations. The apnea hypopnea index (AHI) and breath-by-breath peak decibel levels were measured. Snore breaths were tallied to determine the frequency and intensity of snoring. Regression models were used to determine the relationship between objective measures of snoring and OSA (AHI ≥ 5 events/h). The area under the curve (AUC) for the receiver operating characteristic (ROC) was used to predict OSA. Snoring intensity exceeded 45 dB(A) in 66% of the 162 participants studied, with 14% surpassing the 53 dB(A) threshold for noise pollution. Snoring intensity and frequency were independent predictors of OSA. AUCs for snoring intensity and frequency were 77% and 81%, respectively, and increased to 87% and 89%, respectively, with the addition of age and sex as predictors. Snoring represents a source of noise pollution in the bedroom and constitutes an important target for mitigating sound and its adverse effects on bed partners. Precise breath-by-breath identification and quantification of snoring also offers a way to risk stratify otherwise healthy snorers for OSA.


2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Eileen R. Chasens ◽  
Susan M. Sereika ◽  
Martin P. Houze ◽  
Patrick J. Strollo

Objective.This study examined the association between obstructive sleep apnea (OSA), daytime sleepiness, functional activity, and objective physical activity.Setting.Subjects (N=37) being evaluated for OSA were recruited from a sleep clinic.Participants. The sample was balanced by gender (53% male), middle-aged, primarily White, and overweight or obese with a mean BMI of 33.98 (SD=7.35;median BMI=32.30). Over 40% reported subjective sleepiness (Epworth Sleepiness Scale (ESS) ≥10) and had OSA (78% with apnea + hypopnea index (AHI) ≥5/hr).Measurements.Evaluation included questionnaires to evaluate subjective sleepiness (Epworth Sleepiness Scale (ESS)) and functional outcomes (Functional Outcomes of Sleep Questionnaire (FOSQ)), an activity monitor, and an overnight sleep study to determine OSA severity.Results.Increased subjective sleepiness was significantly associated with lower scores on the FOSQ but not with average number of steps walked per day. A multiple regression analysis showed that higher AHI values were significantly associated with lower average number of steps walked per day after controlling patient's age, sex, and ESS.Conclusion.Subjective sleepiness was associated with perceived difficulty in activity but not with objectively measured activity. However, OSA severity was associated with decreased objective physical activity in aging adults.


FACE ◽  
2021 ◽  
Vol 2 (1) ◽  
pp. 65-70
Author(s):  
Paul B. Lee ◽  
Michael T. Chung ◽  
Jared Johnson ◽  
Jordyn Lucas ◽  
Caitlin R. Priest ◽  
...  

Objective: There is a high prevalence of obstructive sleep apnea (OSA) in pediatric and adult Down Syndrome (DS) patients that is refractory to adenotonsillectomy and continuous positive airway pressure. Newer treatment modalities have emerged with improved outcomes. The objective is to provide an updated systematic review and meta-analysis to analyze the clinical outcomes of OSA in pediatric and adult DS patients with hypoglossal nerve stimulation using Inspire, midline posterior glossectomy plus lingual tonsillectomy (MPG + LT), and combined genioglossus advancement plus radiofrequency (GGS + RF). Methods: A comprehensive literature search of PubMed and Google Scholar was performed followed by a meta-analysis. Studies with preoperative and post-operative Apnea Hypopnea Index (AHI) values were included with patients serving as their own control. Results: Across 5 studies, 56 patients were analyzed. The mean reduction in AHI was statistically significant before vs. after procedure ( P < .001 for hypoglossal nerve stimulation using Inspire with a paired 2-tailed t-test and P = .031 for MPG + LT). Although individual patient AHI values were unavailable in the GGS + RF study, the standard difference in mean AHI was also significant for GGS + RF with P = .001. Device malfunction was the most common complication for Inspire while postoperative bleeding was observed for MPG + LT and nasopharyngeal obstruction and retropalatal collapse were observed for GGS + RF. Conclusion: This review reveals significant improvement in AHI with Inspire, MPG + LT, and GGS + RF for DS patients with refractory OSA. Further investigation is needed for comparison between these 3 therapies.


SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A319-A320
Author(s):  
Elena Stuewe ◽  
Aarti Grover ◽  
Peter Ostrow ◽  
Greg Schumaker ◽  
Joel Oster ◽  
...  

Abstract Introduction Hypoglossal nerve stimulation (HNS) is an efficacious option for treating moderate to severe obstructive sleep apnea (OSA). However, there is sparse evidence regarding tolerance and adherence to HNS therapy in patients with a diagnosis of insomnia. Report of case(s) A 57-year-old man with well-controlled depression presented for evaluation for HNS therapy. He had been diagnosed with moderate OSA with an apnea-hypopnea index of 22/hour, intolerant of continuous positive airway pressure and mandibular advancement device. He underwent uvulopalatopharyngoplasty without significant improvement. At the time of initial evaluation, he denied history of insomnia and prior sleep aid use. He subsequently underwent successful HNS device implantation and activation. One week after HNS initiation, the patient reported new symptoms of significant difficulty with sleep onset and inability to fall back asleep, which was worse than his untreated OSA symptoms. Device interrogation did not reveal any hardware problems. Adjustments to start delay, pause time and device configuration with awake endoscopy did not improve tolerance. Subsequently, the patient disclosed a remote history of insomnia, which was treated with multiple hypnotics in addition to cognitive-behavioral therapy for insomnia (CBTi) and had resolved. He was diagnosed with recurrent chronic insomnia, for which eszopiclone was initiated without significant improvement. He eventually agreed to CBTi, with partial improvement in device tolerance and improvement in insomnia symptoms. Conclusion This case highlights that HNS therapy adherence can be affected by prior history of, or a current diagnosis of insomnia. Our patient had a predisposition for insomnia that was well controlled prior to HNS therapy initiation. The onset of recurrent insomnia with HNS activation suggests that HNS was a precipitating factor for his now chronic insomnia. Although there is insufficient evidence to suggest whether history of insomnia should affect the decision to initiate HNS therapy, this case illustrates the importance of screening for insomnia at pre-implant evaluation. Our center is now routinely screening for a history of insomnia to identify patients who may benefit from treatment prior to HNS implantation. Larger studies are needed to explore a possible relationship between insomnia and HNS adherence. Support (if any):


PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0258040
Author(s):  
Eric Yeh ◽  
Eileen Wong ◽  
Chih-Wei Tsai ◽  
Wenbo Gu ◽  
Pai-Lien Chen ◽  
...  

Many wearables allow physiological data acquisition in sleep and enable clinicians to assess sleep outside of sleep labs. Belun Sleep Platform (BSP) is a novel neural network-based home sleep apnea testing system utilizing a wearable ring device to detect obstructive sleep apnea (OSA). The objective of the study is to assess the performance of BSP for the evaluation of OSA. Subjects who take heart rate-affecting medications and those with non-arrhythmic comorbidities were included in this cohort. Polysomnography (PSG) studies were performed simultaneously with the Belun Ring in individuals who were referred to the sleep lab for an overnight sleep study. The sleep studies were manually scored using the American Academy of Sleep Medicine Scoring Manual (version 2.4) with 4% desaturation hypopnea criteria. A total of 78 subjects were recruited. Of these, 45% had AHI < 5; 18% had AHI 5–15; 19% had AHI 15–30; 18% had AHI ≥ 30. The Belun apnea-hypopnea index (bAHI) correlated well with the PSG-AHI (r = 0.888, P < 0.001). The Belun total sleep time (bTST) and PSG-TST had a high correlation coefficient (r = 0.967, P < 0.001). The accuracy, sensitivity, specificity in categorizing AHI ≥ 15 were 0.808 [95% CI, 0.703–0.888], 0.931 [95% CI, 0.772–0.992], and 0.735 [95% CI, 0.589–0.850], respectively. The use of beta-blocker/calcium-receptor antagonist and the presence of comorbidities did not negatively affect the sensitivity and specificity of BSP in predicting OSA. A diagnostic algorithm combining STOP-Bang cutoff of 5 and bAHI cutoff of 15 events/h demonstrated an accuracy, sensitivity, specificity of 0.938 [95% CI, 0.828–0.987], 0.944 [95% CI, 0.727–0.999], and 0.933 [95% CI, 0.779–0.992], respectively, for the diagnosis of moderate to severe OSA. BSP is a promising testing tool for OSA assessment and can potentially be incorporated into clinical practices for the identification of OSA. Trial registration: ClinicalTrial.org NCT03997916 https://clinicaltrials.gov/ct2/show/NCT03997916?term=belun+ring&draw=2&rank=1


SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A180-A180
Author(s):  
Victoria Pak ◽  
David Maislin ◽  
Brendan Keenan ◽  
Raymond Townsend ◽  
Bryndis Benediktsdottir ◽  
...  

Abstract Introduction Continuous positive airway pressure (CPAP) therapy may improve insulin sensitivity and glucose tolerance seen in individuals with obstructive sleep apnea (OSA), however there is a lack of studies on whether obesity modifies the effect. We examined the baseline and follow-up levels of insulin and glucose following 4 months of CPAP treatment among participants with body mass index (BMI) &lt;30, 30≤ BMI&lt;35, and BMI≥35 kg/m2. Methods We identified 221 adults (84% males) with newly diagnosed OSA in the Penn Icelandic Sleep Apnea (PISA) Study, with a mean (±SD) BMI 31.7 +- 4.2 kg/m2 and apnea-hypopnea index (AHI) of 35.7+-15.6 events/hour. Associations between changes in natural log of the biomarkers within BMI groups were explored, controlling for a priori baseline covariates of age, baseline BMI, race, sex, site, and current smoking status. Results The mean proportional change (from baseline to follow-up) in log-transformed glucose in CPAP adherent participants was significantly larger in the BMI ≥35 and 30≤ BMI&lt;35 groups compared to BMI &lt;30. Within the BMI ≥35 group, the baseline to follow up increase in glucose post-CPAP was 1.08 (95% CI 1.01–1.15), while there were no significant changes in the other 2 BMI groups. A mediation analysis was performed with models including BMI change, and glucose was found to be significantly different between groups. There was no statistically significant association for insulin. Conclusion Our findings show that obesity modifies the effect of four months of CPAP on glucose levels. Support (if any) 1P01-1HL094307


OTO Open ◽  
2019 ◽  
Vol 3 (2) ◽  
pp. 2473974X1985147
Author(s):  
Jason E. Cohn ◽  
George E. Relyea ◽  
Srihari Daggumati ◽  
Brian J. McKinnon

Objective To examine the effects of multilevel sleep surgery, including palate procedures, on obstructive sleep apnea parameters in the pediatric population. Study Design A case series with chart review was conducted to identify nonsyndromic, neurologically intact pediatric patients who underwent either uvulectomy or uvulopalatopharyngoplasty as part of multilevel sleep surgery from 2011 through 2017. Setting A tertiary care, university children’s hospital. Subjects and Methods Unpaired Student t test was used to compare average pre- and postsurgical apnea-hypopnea index (AHI) and oxygen saturation nadir (OSN). Paired Student t test was used to compare the mean pre- and postsurgical AHI and OSN within the same patient for the effects of adenotonsillectomy (T&A) vs multilevel sleep surgery. Results In patients who underwent T&A previously, multilevel sleep surgery, including palate procedures, resulted in improved OSA severity in 6 (86%) patients and worsened OSA in 1 (14%) patient. Multilevel sleep surgery, including palate procedures, significantly decreased mean AHI from 37.98 events/h preoperatively to 8.91 events/h postoperatively ( P = .005). However, it did not significantly decrease OSN. Conclusion This study includes one of the largest populations of children in whom palate procedures as a part of multilevel sleep surgery have been performed safely with no major complications and a low rate of velopharyngeal insufficiency. Therefore, palatal surgery as a part of multilevel sleep surgery is not necessarily the pariah that we have traditional thought it is in pediatric otolaryngology.


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