Upper Airway Stimulation Therapy Research Articles

Troubleshooting Upper Airway Stimulation Therapy Using Drug-Induced Sleep Endoscopy.

This study assesses the utility of drug-induced sleep endoscopy (DISE) in guiding further treatment for patients with obstructive sleep apnea (OSA) who have difficulty tolerating upper airway stimulation (UAS) or have inadequate response to therapy. We conducted a retrospective analysis of UAS patients at our institution who underwent DISE, post-UAS, and evaluated the efficacy of different electrode configurations and maneuvers. A tertiary care hospital. Out of 379 patients who received UAS therapy, 34 patients who underwent DISE post-UAS (DISE-UAS) were included. Palatal coupling (PC) was assessed with UAS stimulation alone, jaw thrust alone, and both simultaneously during DISE. Among 34 patients, 5 had suboptimal adherence to UAS therapy, 19 had suboptimal therapy efficacy with residual OSA burden, and 10 had both. During DISE-UAS, PC was observed in 7 patients (21%) with UAS stimulation alone, 9 patients (26%) with jaw thrust alone, and 8 patients (24%) with both maneuvers combined. Notably, 10 patients (29%) did not exhibit PC with any maneuver. Based on DISE-UAS findings, 13 patients were recommended oral appliance therapy (OAT), and 8 patients underwent further surgical interventions. DISE-UAS is a valuable adjunct in troubleshooting UAS therapy for patients intolerant to CPAP or with suboptimal therapy efficacy. This study provides an algorithm for targeted multimodality therapy based on DISE findings, facilitating personalized management approaches.

Treatment of a floppy epiglottis with upper airway stimulation therapy.

To evaluate the efficacy of upper airway stimulation therapy in patients with a floppy epiglottis who have experienced continuous positive airway pressure failure or intolerance. A retrospective single-center cohort study was conducted. Patients who received an Inspire Upper Airway Stimulation system and had a 1-year follow-up were included. Baseline and one-year in-laboratory polysomnography examinations were performed. Patient characteristics, Epworth Sleepiness Scale scores and upper airway stimulation device settings were collected. A total of 75 patients were included, of whom 10 had a floppy epiglottis. Patients with a floppy epiglottis had a significant therapeutic response to upper airway stimulation therapy, similar to patients without a floppy epiglottis. According to the Sher's success criteria, 90% of patients with a floppy epiglottis and 68% of patients without a floppy epiglottis were responders to therapy (p = 0.149). In the floppy epiglottis group, the apnea-hypopnea index decreased from 35.1 ± 5.5 events/hour to 11.2 ± 11.3 events/hour (95% CI (15.0, 32.9), p < 0.001), similarly in the non-floppy epiglottis group, the decline was from 36.4 ± 8.3 events/hour to 14.4 ± 9.5 events/hour (95% CI (18.6, 25.2), p < 0.001, between groups p = 0.659). Comparable reductions were observed for the other respiratory parameters. Treatment of patients with obstructive sleep apnea and a floppy epiglottis can be challenging. Continuous positive airway pressure may aggravate the epiglottis collapse. Upper airway stimulation therapy can be considered an effective alternative treatment option for patients with a floppy epiglottis who have encountered either continuous positive airway pressure failure or intolerance.

Reduced usage of upper airway stimulation therapy in patients with comorbid insomnia and obstructive sleep apnea.

Upper airway stimulation (UAS) is a hybrid surgical-medical device used to treat moderate-to-severe obstructive sleep apnea (OSA). Comorbid insomnia and OSA (COMISA) is present in ∼50% of these patients. Our aim was to study UAS outcomes and adherence in patients with COMISA. A retrospective review of 379 patients with OSA who underwent UAS implantation at a single institution between 2014 and 2021. Demographics, OSA severity metrics, and insomnia data were collected. Patients were categorized into OSA alone (OSAa) or COMISA. Objective adherence data were collected from device downloads during follow-up. Data were analyzed with using R Studio (R Foundation for Statistical Computing, Vienna, Austria) and Prism (Boston, MA, USA). Of the 274 patients included, 148 had COMISA (54.0%) and 126 OSAa (46.0%). Average follow-up time was 2.5 years and OSAa had more males than COMISA (P < .001). Patients with COMISA had higher insomnia severity index scores than OSAa preoperatively (16 vs 8.7; P = .003). All groups showed significant decreases in objective and self-reported OSA outcomes postoperatively, but there was no difference between COMISA and OSAa. Patient with COMISA had decreased device usage (4.9 vs 5.8 h/night; P = .015) and paused therapy more often than patients with OSAa (1.4 vs 0.4 pauses/night; P < .001). Multivariate linear regression, when controlling for sex as a covariate, showed insomnia to be an independent predictor of lower UAS hours/night and more pauses/night (P < .01). Patients with COMISA use UAS therapy for shorter durations and require more breaks from therapy when compared with those with OSAa. Future research is needed to explore the underlying mechanism and improve UAS treatment adherence in patients with COMISA. Kaffenberger TM, Chandna M, Kaki P, etal. Reduced usage of upper airway stimulation therapy in patients with comorbid insomnia and obstructive sleep apnea. J Clin Sleep Med. 2023;19(12):1997-2004.

Upper Airway Stimulation Therapy Effect on Blood Pressure.

Upper airway stimulation (UAS) therapy has become increasingly utilized to treat obstructive sleep apnea, which is an independent risk factor for the development of hypertension. This study examines the impact of this therapy on blood pressure (BP). Retrospective cross-sectional cohort study. Tertiary center, Military Health System. Patients who underwent UAS implantation at Brooke Army Medical Center between July 2015 and July 2020 were included if they used their device for at least 25 h/wk. Pre- and postoperative systolic BP, diastolic blood pressure (DBP), calculated mean arterial pressure (MAP), and the apnea-hypopnea index (AHI) were compared using paired ttest or Wilcoxon's signed-rank test. Thirty patients met the inclusion criteria. The median age was 60, and the median body mass index was 29.9 kg/m2 . The mean time between pre- and postoperative BP measurements was 11.6 months. AHI decreased from 35.1to 16.5 events/h(p < .001). DBP decreased from 78.5 (73.8, 85.0) to 74.5 mm Hg (68.8, 81.3), with a mean difference of -3.7 mm Hg (p = .002). MAP decreased from 94.8 (89.6, 100.6) to 90.2 mm Hg (84.3, 100.0), with a mean difference of -3.7 mm Hg (p = .004). UAS therapy was associated with a significant reduction in DBP, MAP, and AHI. These reductions in BP could potentially lead to favorable decreases in cardiovascular morbidity.

Upper Airway Stimulation in Patients with Obstructive Sleep Apnea: Long-Term Surgical Success, Respiratory Outcomes, and Patient Experience.

Introduction Upper airway stimulation (UAS) with electric activation of the hypoglossal nerve has emerged as a promising treatment for patients with moderate-to-severe obstructive sleep apnea. Objective To retrospectively analyze objective and subjective outcome measures after long-term follow-up in obstructive sleep apnea patients receiving upper airway stimulation. Methods An observational retrospective single-center cohort study including a consecutive series of patients diagnosed with obstructive sleep apnea receiving upper airway stimulation. Results Twenty-five patients were included. The total median apnea-hypopnea index (AHI) significantly decreased from 37.4 to 8.7 events per hour at the 12-month follow-up ( p < 0.001). The surgical success rate was 96%. Adverse events were reported by 28% of the patients. Conclusion Upper airway stimulation is an effective and safe treatment for obstructive sleep apnea in patients with continuous positive airway pressure (CPAP) failure or intolerance. However, it is possible that the existing in and exclusion criteria for UAS therapy in the Netherlands have positively influenced our results.

Prevalence of insomnia and restless legs syndrome in patients with upper airway stimulation therapy and effects on treatment outcomes

ObjectiveThis study aims to explore the prevalence of insomnia and restless legs syndrome (RLS) and the possible effects of these conditions on treatment adherence and outcomes in patients with upper airway stimulation (UAS) therapy for the treatment of obstructive sleep apnea. MethodsConsecutive patients who underwent UAS system implantation were retrospectively studied. Patients without insomnia or RLS, insomnia, RLS, and both insomnia and RLS were compared. The apnea-hypopnea index (AHI), in-lab UAS titration data, Epworth Sleepiness Scale (ESS), and adherence to UAS therapy were compared. ResultsSixty-four patients who had UAS implantation and completed post-implant in-lab UAS titration were identified. Insomnia was present in 47%, RLS in 28%, and both insomnia and RLS in 14%. During in-lab titration, the AHI improved for all groups and did not differ across groups. The arousal index on in-lab titration was higher in patients with both RLS and insomnia compared to those without these conditions. At the time of the in-lab titration, the hours of UAS therapy usage were reduced for patients with RLS (4.7 ± 1.9 h/night, p = 0.027) compared to those without RLS (6.0 ± 2.0 h/night). The ESS was higher in patients with RLS compared to those without RLS at in-lab titration. ConclusionInsomnia and RLS are common in patients using UAS therapy. A decrease in UAS usage and higher ESS were present in patients with RLS. Further research evaluating the long-term effects of insomnia and RLS in UAS therapy usage and benefit is needed.

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.

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)

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.

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

Daytime polysomnography to perform titration for upper airway stimulation in patients with obstructive sleep apnea.

PurposeUpper airway stimulation (UAS) is an innovative treatment for patients with obstructive sleep apnea (OSA). UAS titrations are performed 3 months after activation of the device to optimize its effectiveness. In general, these titrations are performed during an in-laboratory overnight polysomnography (PSG). However, overnight titrations are expensive and can be logistically challenging because they are labor-intensive which causes shortage of sleep technicians available for night shifts. In addition, recently, overnight PSGs were postponed and canceled due to the COVID-19 pandemic. We aimed to assess the feasibility of a daytime PSG to perform titration of UAS therapy as an alternative for a conventional overnight PSG.MethodsWe performed a prospective single-center observational cohort study. Patients were included when planned for UAS titration; this was approximately 6 months after UAS activation. Data on sleep architecture, patient experience, and respiratory outcomes were collected to evaluate the feasibility. An overnight follow-up PSG 12 months after implantation was used to compare sleep architecture and therapy response.ResultsOf 23 patients, four were excluded from analysis because of technical issues during PSG. Even though patients slept significantly shorter during the daytime PSG, this was enough time to complete the titration successfully with 30-min sleep in final therapeutic settings in 84% of the patients. Patients (94%) had a positive experience with the daytime titration. Respiratory outcomes were significantly reduced during titration and were maintained at the 12-month follow-up.ConclusionDaytime titrations are a valuable alternative for conventional overnight titrations. Our findings suggest the implementation of daytime titrations as standard of care. This will contribute to easier logistics and better work circumstances for sleep technicians without jeopardizing titration quality.

433 Insomnia and Restless Legs Syndrome in Patients with Upper Airway Stimulation Therapy

Abstract Introduction Insomnia and restless legs syndrome (RLS) are common sleep disorders that may impact obstructive sleep apnea (OSA) treatment. To our knowledge, no studies have investigated whether these comorbidities affect upper airway stimulation (UAS) therapy adherence and outcomes. This study aims to explore possible effects of insomnia and RLS in patients using UAS therapy. Methods All patients who underwent UAS system implantation for treatment of OSA at our facility were retrospectively studied. Pre- and post-implant histories and data, including diagnostic sleep testing, otolaryngology evaluation, activation results, and treatment evaluation, were analyzed. Patients with no insomnia or RLS were compared to patients with insomnia, RLS, or both. Apnea-hypopnea index (AHI), Epworth Sleepiness Scale (ESS), and adherence were compared pre- and post-treatment for each group. Results Sixty-four patients who have undergone UAS implantation at our center have completed post-treatment in-lab titration and evaluation of their UAS system. Insomnia was present in 47%, RLS in 28%, and both insomnia and RLS in 14%. In all groups, the overall AHI during in-lab titration was &amp;gt;50% lower than the pre-treatment AHI (16.1+/-14.3/h vs 32.5+/-13.1/h, p&amp;lt;0.001). While the trend in AHI reductions suggested a lower AHI in those without insomnia or RLS, the reduction did not reach statistical significance (no insomnia or RLS 15.7+/-12.9/h, insomnia 16.9+/-16.7/h, RLS 19.0+/-15.5/h, both insomnia and RLS 23.4+/-18.4/h). UAS therapy usage was reduced in patients with RLS (3.9+/-2.6 h/night, p=0.029) and in patients with both insomnia and RLS (3.9+/-1.3 h/night, p=0.046) compared to patients with neither comorbidity (5.9+/-1.9 h/night). Mean reduction in ESS was similar across groups, averaging from 11+/-5 pre-treatment to 7+/-5 post-treatment (p&amp;lt;0.001). Conclusion Insomnia and RLS are common in patients using UAS therapy for OSA. Pre- and post-treatment residual AHI and ESS significantly improved in all patient groups assessed. A decrease in UAS usage was present in patients with RLS and both RLS and insomnia. Our study suggests that identification and treatment of RLS and insomnia may play an important role for UAS therapy adherence and efficacy, thus, optimizing care. Support (if any):

459 The Effect of Upper Airway Stimulation Therapy on Blood Pressure

Abstract Introduction Upper airway stimulation (UAS) therapy is a novel technique in the treatment of Obstructive Sleep Apnea (OSA). UAS therapy is indicated for patients with moderate to severe OSA who fail therapy with Continuous Positive Airway Pressure (CPAP) and/or the use of a dental appliance. Although research suggests that CPAP can modestly improve patients’ Blood Pressure (BP), little is known about the effect of UAS on BP. Methods Via a retrospective cross-sectional cohort study, we identified all patients undergoing UAS surgery at Brook Army Medical Center from July 2015 through July 2020. We captured pre-operative and post-operative data from a structured electronic medical record review, including Polysomnographic data and BP measurements at designated time points. We measured UAS therapy compliance in hours of usage per week. Statistical analysis includes paired T-tests to determine whether changes in BP and AHI were significant when comparing preoperative and postoperative values. Results We report data for 12 patients treated with Upper Airway Stimulation therapy in our cohort. The mean pre-operative Systolic Blood Pressure (SBP) is 128.3±7 mmHg, the mean post-operative SBP is 122.8±10 mmHg with a mean difference of -5.4mmHg (standard error for difference 2.9mmHg). The mean pre-operative Diastolic Blood Pressure (DBP) is 80.0±6 mmHg, the mean post-op DBP is 76.4±8 mmHg, with a mean difference of -3.6mmHg (standard error for difference 1.9 mmHg). Neither of these are statistically significant, with P values of 0.09 and 0.08 respectively. The mean pre-operative Mean Arterial Pressure (MAP) is 96.1±6 mmHg, the mean post-op MAP is 91.9± 8 mmHg, with a mean difference of -4.2 mmHg (standard error for difference 1.7 mmHg). This represents a statistically significant difference with a P value of 0.03. Seven patients carried a pre-operative diagnosis of Hypertension whereas five did not. There is not a statistical difference in BP changes between these subgroups. Conclusion Upper Airway Stimulation surgery appears to decrease SBP, DBP, and MAP measurements with a similar magnitude as Positive Airway Pressure Therapy. In our cohort, only MAP changes appear to reach statistically significance. Further studies are warranted to elucidate the clinical significance of UAS on physiologic parameters such as blood pressure. Support (if any):

Sleep apnea surgery in the elderly

With a growing population of elderly patients in the United States seeking treatment for obstructive sleep apnea, age is becoming an increasingly important consideration for sleep surgeons. The effects of obstructive sleep apnea on elderly patients may be different for older patients, specifically when it comes to the cardiovascular and mortality risk observed in younger patient populations. Recent reports indicate that traditional structural surgery for elderly patients may be less effective and that postoperative complication rates are higher. In contrast, early reports on upper airway stimulation therapy suggest improved efficacy with increasing age. Although advanced age itself is not a contraindication for surgery, the balance of risks vs benefits should be carefully weighed in the elderly patient population.

The practicality of a two-incision surgical approach for hypoglossal nerve stimulator implantation.

Determine the feasibility of a two-incision surgical approach to hypoglossal nerve stimulator implantation based on anatomic considerations. Upper airway stimulation (UAS) using the Inspire system uses three implanted devices-the implantable pulse generator (IPG), stimulation lead and sensing chest wall lead. The traditional surgical approach requires three skin incisions located on the submandibular neck, anterosuperior chest wall and inferolateral chest wall. Our surgical team sought to determine the anatomic considerations of combining the two chest wall incisions into one. In order to minimize morbidity and reduce operative time, the chest wall sensing lead was placed posterolateral to the IPG site via the same incision. Using an adult cadaver for anatomical analysis, access to the third and fourth intercostal spaces was made more difficult by the pectoralis major humeral head and upper arm. The intercostal space was narrower, the musculature along the anterior axillary line and anterior chest wall was devoid of the innermost intercostal muscle group found more laterally. Furthermore, there were much thinner external and internal intercostal muscle components as they transitioned to a membranous layer anteriorly in comparison to the inferolateral chest wall. Lack of the innermost intercostal muscle and thinning of the external and internal intercostal muscles lateral to the IPG site leaves little barrier between the thoracic musculature and parietal pleural increasing the risk of complications such as pleurisy and pneumothorax. Given the anatomical findings, a two-incision surgical approach for UAS therapy is at higher risk for complications.

Gender differences in the preference for upper airway stimulation therapy among Japanese patients with obstructive sleep apnea already treated with continuous positive airway pressure

Although upper airway stimulation (UAS) is becoming an established therapy for obstructive sleep apnea (OSA) in Western countries, it is not available in Japan, where invasive procedures tend to be avoided, especially by women. We, therefore, performed surveillance concerning the preference for UAS among Japanese OSA patients receiving CPAP treatment. Preference for UAS and the reasons were obtained from responses to an original questionnaire administered to 101 CPAP users. We also obtained polysomnography parameters and the current CPAP use data to determine adherence and pressure and evaluated the relationship between such factors and the preference. Among 101 patients (mean age 59.1 ± 13.1 years old, men 75.2%, mean body mass index 28.2 ± 6.1 kg/m2, mean apnea–hypopnea index at the diagnosis 51.7 ± 24.4/h, mean usage time per day 4.9 ± 2.3 h/day), 21 patients (20.8%; M/F = 15/6) were willing to use UAS, while 57 (56.5%; M/F = 43/14) were unwilling, and 23 (22.7%; M/F = 18/5) showed neutral preference. The proportion of patients who preferred UAS did not differ significantly among age groups. We found no significant factors independently affecting the preference. However, in the group willing to use UAS, the rate of days when CPAP usage exceeded 4 h per month was an independent negative factor predicting the preference only among women in a multivariable analysis (odds ratio 0.96, 95% confidence interval 0.92–1.00, p = 0.04). About 20% of patients showed a positive attitude toward UAS treatment among current Japanese CPAP users, and CPAP adherence was an independent negative factor predicting preference among women.

Hypoglossal nerve stimulation therapy does not alter tongue protrusion strength and fatigability in obstructive sleep apnea.

Hypoglossal nerve stimulation (HNS) is an effective surgical alternative for patients with obstructive sleep apnea (OSA). HNS therapy relies on the stimulation of the hypoglossal nerve to open the upper airways. This stimulation could lead to alterations in tongue strength and fatigability, which could alter treatment outcome over time. The aim of the study was to investigate whether HNS alters tongue strength and fatigability. Tongue protrusion strength (peak pressure in kPa) and fatigability (time to task failure during 50% of peak pressure contraction) were measured with a pressure transducer at least 2 months after HNS implantation (n = 30). These results were compared to a group of patients with OSA (n = 38) and a non-OSA control group (n = 35). Median tongue protrusion strength was lower (54.7 [43.8, 63.0] versus 60.7 [53.7, 66.0] kPa, P = .013) and fatigue occurred more quickly (21.3 [17.4, 26.3] versus 26.0 [19.3, 31.3] seconds, P = .017) in the patients with OSA compared to the non-OSA control group. In multiple regression analysis, age was a significant factor for tongue strength and diagnosis of OSA for tongue fatigability. Tongue strength and fatigability did not differ between patients with OSA with conservative therapy or observation versus after HNS implantation (51.8 [41.3, 63.4] versus 56.3 [45.0, 62.3] kPa, P = .502; 20.8 [16.3, 26.2] versus 21.8 [18.3, 26.8] seconds, P = .418). Tongue strength decreases with age. Tongue fatigability is more pronounced in people with OSA. However, approximately 1.5 years of HNS therapy on average does not alter tongue strength or fatigability compared to an OSA control group. Registry: ClinicalTrials.gov; Title: Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy; Identifier: NCT03980158.

Results of the ADHERE upper airway stimulation registry and predictors of therapy efficacy.

Objective/HypothesisThe ADHERE Registry is a multicenter prospective observational study following outcomes of upper airway stimulation (UAS) therapy in patients who have failed continuous positive airway pressure therapy for obstructive sleep apnea (OSA). The aim of this registry and purpose of this article were to examine the outcomes of patients receiving UAS for treatment of OSA.Study DesignCohort Study.MethodsDemographic and sleep study data collection occurred at baseline, implantation visit, post‐titration (6 months), and final visit (12 months). Patient and physician reported outcomes were also collected. Post hoc univariate and multivariate analysis was used to identify predictors of therapy response, defined as ≥50% decrease in Apnea‐Hypopnea Index (AHI) and AHI ≤20 at the 12‐month visit.ResultsThe registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6‐month follow‐up and 382 have completed the 12‐month follow‐up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6–45.0) to 9.5 (IQR, 4.0–18.5); mean, 35.8 ± 15.4 to 14.2 ± 15.0, P < .0001. Epworth Sleepiness Scale was similarly improved from 11.0 (IQR, 7–16) to 7.0 (IQR, 4–11); mean, 11.4 ± 5.6 to 7.2 ± 4.8, P < .0001. Therapy usage was 5.6 ± 2.1 hours per night after 12 months. In a multivariate model, only female sex and lower baseline body mass index remained as significant predictors of therapy response.ConclusionsAcross a multi‐institutional study, UAS therapy continues to show significant improvement in subjective and objective OSA outcomes. This analysis shows that the therapy effect is durable and adherence is high.Level of Evidence2 Laryngoscope, 130:1333–1338, 2020

Upper Airway Stimulation vs Positive Airway Pressure Impact on BP and Sleepiness Symptoms in OSA

Positive airway pressure (PAP) and upper airway stimulation (UAS) are approved OSA treatment options. Although the effect of PAP on improvement in BP and daytime sleepiness (defined according to the Epworth Sleepiness Scale [ESS]) has been established, the impact of UAS on BP remains unclear. This study hypothesized that PAP and UAS will confer improvements in BP and daytime sleepiness. Clinic-based BP and ESS scores were compared between 517 patients with OSA (apnea-hypopnea index, 15-65) and BMI≤ 35kg/m2 initiating PAP therapy (2010-2014) at the Cleveland Clinic and 320 patients with UAS implantation (2015-2017) via an international registry with 2- to 6-month follow-up. Mixed effect models were used to compare outcomes in 201 patients in each arm following propensity matching. PAP showed greater improvement in diastolic BP (mean difference of change between groups, 3.7mmHg; P< .001) and mean arterial pressure (mean difference of change between groups, 2.8mmHg; P= .008) compared with UAS. UAS showed greater improvement in ESS scores vsPAP (mean difference of change between PAP and UAS groups, -0.8; P= .046). UAS therapy usage was 6.2 h/week greater than PAP-treated patients (95%CI, 3.3-9.0). Results were consistent following adjustment for therapy adherence. PAP showed greater improvement in BP, potentially reflecting an enhanced ability of PAP to exert beneficial mechanical intrathoracic cardiac and vascular influences. BP measurement error in the UAS group may also have accounted for findings. Greater improvement in sleepiness symptoms was noted with UAS compared with PAP.

Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy

Change in Tongue Strength and Fatigue After Upper Airway Stimulation Therapy