Upper Airway Stimulation for OSA

2016 ◽  
Vol 155 (1) ◽  
pp. 188-193 ◽  
Author(s):  
David T. Kent ◽  
Jake J. Lee ◽  
Patrick J. Strollo ◽  
Ryan J. Soose
Keyword(s):  
Outcome Measures ◽  
Case Series ◽  
Upper Airway ◽  
Positive Pressure ◽  
Apnea Hypopnea Index ◽  
Upper Airway Stimulation ◽  
Pressure Therapy ◽  
Early Results ◽  
Obstructive Sleep ◽  
Adherence Monitoring

Objective To review outcome measures and objective adherence data for patients treated with hypoglossal nerve stimulation (HNS) therapy for moderate to severe obstructive sleep apnea (OSA). Study Design Case series with chart review. Setting Academic sleep medicine center. Subjects and Methods The first 20 implanted patients to complete postoperative sleep laboratory testing were assessed. All patients had moderate to severe OSA, were unable to adhere to positive pressure therapy, and met previously published inclusion criteria for the commercially available implantable HNS system. Data included demographics, body mass index (BMI), apnea-hypopnea index (AHI), Epworth Sleepiness Score (ESS), nightly hours of device usage, and procedure- and therapy-related complications. Results Mean age was 64.8 ± 12.0 years, with 50% female. Mean BMI was unchanged postoperatively (26.5 ± 4.2 to 26.8 ± 4.5 kg/m2; P > .05). Mean AHI (33.3 ± 13.0 to 5.1 ± 4.3; P < .0001) and mean ESS (10.3 ± 5.2 to 6.0 ± 4.4; P < .01) decreased significantly. Seventy percent (14/20) of patients achieved a treatment AHI <5, 85% (17/20) an AHI <10, and 95% (19/20) an AHI <15. Average stimulation amplitude was 1.89 ± 0.50 V after titration. Adherence monitoring via device interrogation showed high rates of voluntary device use (mean 7.0 ± 2.2 h/night). Conclusion For a clinical and anatomical subset of patients with OSA, HNS therapy is associated with good objective adherence, low morbidity, and improved OSA outcome measures. Early results at one institution suggest that HNS therapy can be implemented successfully into routine clinical practice, outside of a trial setting.

Zungenschrittmacher zur Behandlung der obstruktiven Schlafapnoe aus klinischer und ökonomischer Sicht

2019 ◽  
pp. XV-XVII
Author(s):  
Wolfgang Galetke
Keyword(s):  
Cost Effectiveness ◽  
Motor Vehicle ◽  
Upper Airway ◽  
Cardiovascular Death ◽  
Apnea Hypopnea Index ◽  
Real World Data ◽  
Upper Airway Stimulation ◽  
Pressure Therapy ◽  
Life Years ◽  
Obstructive Sleep

Background: Upper airway stimulation (UAS) is a treatment approach for patients with moderate-to-severe obstructive sleep apnea who cannot adhere to continuous positive airway pressure therapy. Objective: The objective was to evaluate added patient benefit and cost-effectiveness of UAS in the German health care system. Methods: We used a decision-analytic Markov model to project major adverse cardiovascular or cerebrovascular events (myocardial infarction [MI] or stroke), motor vehicle collision (MVC), mortality, quality-adjusted life years (QALYs), and costs. The assumed reductionin the apnea-hypopnea index with UAS compared to no treatment is based on German real-world data. Other input data were derived from the literature, public statistics, and multivariate regression. Cost-effectiveness was evaluated in Euros per QALY gained, both discounted at 3%. Results: UAS was projected to reduce event risks (10-year relative risk for stroke, MI, cardiovascular death, and MVC: 0.76, 0.64, 0.65, and 0.34, respectively), and to increase survival by 1.27 years. While the UAS strategy incurred an additional 1.02 QALYs within the patient lifetime, there were also additional costs of EUR 45,196, resulting in an incremental cost-effectiveness ratio of EUR 44,446 per QALY gained. Conclusions: In the present model-based analysis, UAS therapy provides meaningful benefit to patient-relevant endpoints and is a cost-effective therapy in the German setting.

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

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A171-A172
Author(s):  
Mohammed Jomha ◽  
Shalini Manchanda ◽  
Stephanie Stahl ◽  
Noah Parker
Keyword(s):  
Restless Legs Syndrome ◽  
Statistical Significance ◽  
Upper Airway ◽  
Post Treatment ◽  
Apnea Hypopnea Index ◽  
Upper Airway Stimulation ◽  
Therapy Adherence ◽  
Restless Legs ◽  
Obstructive Sleep ◽  
Pre Treatment

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 &gt;50% lower than the pre-treatment AHI (16.1+/-14.3/h vs 32.5+/-13.1/h, p&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&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):

scholarly journals The Impact of Upper Airway Stimulation on Swallowing Function

2019 ◽  
Vol 98 (8) ◽  
pp. 496-499 ◽  
Author(s):  
Colin Huntley ◽  
Adam Vasconcellos ◽  
Michael Mullen ◽  
David W. Chou ◽  
Haley Geosits ◽  
...  
Keyword(s):  
Assessment Tool ◽  
Medical Center ◽  
Academic Medical Center ◽  
Upper Airway ◽  
Apnea Hypopnea Index ◽  
Swallowing Function ◽  
Upper Airway Stimulation ◽  
Obstructive Sleep ◽  
The Mean ◽  
The Impact

Objective: To evaluate the impact of upper airway stimulation therapy (UAS) on swallowing function in patients with obstructive sleep apnea. Study Design: Prospective cohort study. Setting: Academic medical center. Participants and Outcome Measures: We recorded demographic, preoperative polysomnogram (PSG), operative, and postoperative PSG data. We assessed the patients swallowing function using the Eating Assessment Tool (EAT-10) dysphagia questionnaire. This was administered both pre- and postoperatively. The postoperative EAT-10 survey was administered at least 3 months after UAS implantation. Results: During the study period, 27 patients underwent UAS implantation, completed the pre- and postoperative EAT-10 questionnaire, met inclusion/exclusion criteria, and were included in the study. The cohort consisted of 16 men and 11 women with a mean age of 63.63 years. The mean preoperative BMI, Epworth Sleepiness Scale (ESS), and Apnea Hypopnea Index (AHI) were 29.37, 10.33, and 34.90, respectively. The mean postoperative ESS and AHI were 5.25 and 7.59, respectively. These were both significantly lower than the preoperative values ( P = .026 and P < .001). The mean pre- and postoperative EAT-10 scores were 0.37 and 0.22, respectively ( P = .461). Conclusion: Our data suggest that UAS likely does not lead to postoperative dysphagia.

Comparison of Traditional Upper Airway Surgery and Upper Airway Stimulation for Obstructive Sleep Apnea

2020 ◽  
pp. 000348942095317
Author(s):  
Colin Huntley ◽  
Maurits Boon ◽  
Samuel Tschopp ◽  
Kurt Tschopp ◽  
Carolyn M Jenks ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Upper Airway ◽  
Apnea Hypopnea Index ◽  
Upper Airway Stimulation ◽  
Sleep Surgery ◽  
Medical Centers ◽  
Academic Medical ◽  
Obstructive Sleep ◽  
Quality Life

Objective: To compare patients with moderate-severe obstructive sleep apnea (OSA) undergoing traditional single and multilevel sleep surgery to those undergoing upper airway stimulation (UAS). Study Design: Case control study comparing retrospective cohort of patients undergoing traditional sleep surgery to patients undergoing UAS enrolled in the ADHERE registry. Setting: 8 multinational academic medical centers. Subjects and Methods: 233 patients undergoing prior single or multilevel traditional sleep surgery and meeting study inclusion criteria were compared to 465 patients from the ADHERE registry who underwent UAS. We compared preoperative and postoperative demographic, quality of life, and polysomnographic data. We also evaluated treatment response rates. Results: The pre and postoperative apnea hypopnea index (AHI) was 33.5 and 15 in the traditional sleep surgery group and 32 and 10 in the UAS group. The postoperative AHI in the UAS group was significantly lower. The pre and postoperative Epworth sleepiness scores (ESS) were 12 and 6 in both the traditional sleep surgery and UAS groups. Subgroup analysis evaluated those patients undergoing single level palate and multilevel palate and tongue base traditional sleep surgeries. The UAS group had a significantly lower postoperive AHI than both traditional sleep surgery subgroups. The UAS group had a higher percentage of patients reaching surgical success, defined as a postoperative AHI <20 with a 50% reduction from preoperative severity. Conclusion: UAS offers significantly better control of AHI severity than traditional sleep surgery. Quality life improvements were similar between groups.

Randomized Controlled Withdrawal Study of Upper Airway Stimulation on OSA

2014 ◽  
Vol 151 (5) ◽  
pp. 880-887 ◽  
Author(s):  
B. Tucker Woodson ◽  
M. Boyd Gillespie ◽  
Ryan J. Soose ◽  
Joachim T. Maurer ◽  
Nico de Vries ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Outcome Measures ◽  
Hypoglossal Nerve ◽  
Upper Airway ◽  
Oxygen Desaturation ◽  
Upper Airway Stimulation ◽  
Randomized Controlled ◽  
Obstructive Sleep ◽  
Therapy Withdrawal

Objective To assess the efficacy and durability of upper airway stimulation via the hypoglossal nerve on obstructive sleep apnea (OSA) severity including objective and subjective clinical outcome measures. Study Design A randomized controlled therapy withdrawal study. Setting Industry-supported multicenter academic and clinical setting. Subjects A consecutive cohort of 46 responders at 12 months from a prospective phase III trial of 126 implanted participants. Methods Participants were randomized to either therapy maintenance (“ON”) group or therapy withdrawal (“OFF”) group for a minimum of 1 week. Short-term withdrawal effect as well as durability at 18 months of primary (apnea hypopnea index and oxygen desaturation index) and secondary outcomes (arousal index, oxygen desaturation metrics, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, snoring, and blood pressure) were assessed. Results Both therapy withdrawal group and maintenance group demonstrated significant improvements in outcomes at 12 months compared to study baseline. In the randomized assessment, therapy withdrawal group returned to baseline, and therapy maintenance group demonstrated no change. At 18 months with therapy on in both groups, all objective respiratory and subjective outcome measures showed sustained improvement similar to those observed at 12 months. Conclusion Withdrawal of therapeutic upper airway stimulation results in worsening of both objective and subjective measures of sleep and breathing, which when resumed results in sustained effect at 18 months. Reduction of obstructive sleep apnea severity and improvement of quality of life were attributed directly to the effects of the electrical stimulation of the hypoglossal nerve.

scholarly journals 0691 Comparison Of Odds Ratio Product And Other Polysomnographic Metrics Among Responders And Non-responders To Upper Airway Stimulation Treatment Of Obstructive Sleep Apnea

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A263-A264
Author(s):  
J L Yu ◽  
B T Keenan ◽  
S T Kuna ◽  
M Younes
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Odds Ratio ◽  
Statistical Significance ◽  
Upper Airway ◽  
Research Society ◽  
Apnea Hypopnea Index ◽  
Upper Airway Stimulation ◽  
Sleep Depth ◽  
Obstructive Sleep

Abstract Introduction Upper airway stimulation (UAS) is a surgical method of treating obstructive sleep apnea (OSA). UAS involves an implantable neuro-stimulator that stimulates the hypoglossal nerve to protrude the tongue during sleep. OSA fails to improve in 22% of patients who receive UAS as defined by a &gt; 50% reduction in Apnea-Hypopnea Index (AHI) and an AHI &lt;20 events/hour. Light sleep may predict UAS failure in that it may limit the stimulus strength that can be applied. The odds ratio product (ORP) is a novel polysomnographic (PSG) metric of sleep depth. We hypothesized that ORP values prior to surgery will be higher (lighter sleep) in non-responders. Having markers that predict surgical success can help reduce unnecessary surgeries. Methods This is a retrospective cohort study of 126 patients (83 responders vs. 43 non-responders) who received UAS implantation for the treatment of OSA. PSG data was obtained from the Stimulation for Apnea Reduction (STAR) trial. Raw baseline PSG data were analyzed and ORP values calculated using Michele Sleep Scoring Software (Cerebra Medical, Winnipeg, CA). In addition, 13 PSG metrics that were considered possibly relevant to surgical outcome were calculated as an exploratory analysis. The measurements included: spindle density, spindle power, spindle frequency, alpha intrusion, Right/Left sleep depth correlation coefficient, respiratory duty cycle, respiratory flow limitation, and arousal intensity. Statistical Analysis: Comparisons between responders and non-responders used parametric t-tests for continuous data and chi-squared or Fisher’s exact tests for categorical data. Statistical significance was based on a Bonferroni-corrected p&lt;0.00357. Results Differences in ORP values and other PSG metrics between responders and non-responders were not statistically significant. Of all PSG metrics only differences in spindle density approached statistical significance (Responders = 2.33 spindles/minute vs Non-Responders = 1.39 spindles/minute, p=0.00360). Conclusion The findings suggest that differences in sleep depth and several other sleep characteristics do not play a significant role in determining response to UAS therapy. Support This project was supported by a Sleep Research Society Career Development Award #023-JP-19

scholarly journals Effect of Upper Airway Stimulation in Patients with Obstructive Sleep Apnea (EFFECT): A Randomized Controlled Crossover Trial

2021 ◽  
Vol 10 (13) ◽  
pp. 2880
Author(s):  
Clemens Heiser ◽  
Armin Steffen ◽  
Benedikt Hofauer ◽  
Reena Mehra ◽  
Patrick J. Strollo ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Crossover Trial ◽  
Upper Airway ◽  
Apnea Hypopnea Index ◽  
Upper Airway Stimulation ◽  
Sham Stimulation ◽  
Randomized Controlled ◽  
Obstructive Sleep ◽  
Significant Difference

Background: Several single-arm prospective studies have demonstrated the safety and effectiveness of upper airway stimulation (UAS) for obstructive sleep apnea. There is limited evidence from randomized, controlled trials of the therapy benefit in terms of OSA burden and its symptoms. Methods: We conducted a multicenter, double-blinded, randomized, sham-controlled, crossover trial to examine the effect of therapeutic stimulation (Stim) versus sham stimulation (Sham) on the apnea-hypopnea index (AHI) and the Epworth Sleepiness Scale (ESS). We also examined the Functional Outcomes of Sleep Questionnaire (FOSQ) on sleep architecture. We analyzed crossover outcome measures after two weeks using repeated measures models controlling for treatment order. Results: The study randomized 89 participants 1:1 to Stim (45) versus Sham (44). After one week, the AHI response rate was 76.7% with Stim and 29.5% with Sham, a difference of 47.2% (95% CI: 24.4 to 64.9, p < 0.001) between the two groups. Similarly, ESS was 7.5 ± 4.9 with Stim and 12.0 ± 4.3 with Sham, with a significant difference of 4.6 (95% CI: 3.1 to 6.1) between the two groups. The crossover phase showed no carryover effect. Among 86 participants who completed both phases, the treatment difference between Stim vs. Sham for AHI was −15.5 (95% CI −18.3 to −12.8), for ESS it was −3.3 (95% CI −4.4 to −2.2), and for FOSQ it was 2.1 (95% CI 1.4 to 2.8). UAS effectively treated both REM and NREM sleep disordered breathing. Conclusions: In comparison with sham stimulation, therapeutic UAS reduced OSA severity, sleepiness symptoms, and improved quality of life among participants with moderate-to-severe OSA.

The Combination of Anatomy and Genioglossus Activity in Predicting the Outcomes of Velopharyngeal Surgery

2017 ◽  
Vol 156 (3) ◽  
pp. 567-574 ◽  
Author(s):  
Di Zhao ◽  
YanRu Li ◽  
JunFang Xian ◽  
Yue Qu ◽  
Xin Cao ◽  
...  
Keyword(s):  
Roc Curve ◽  
Medical Center ◽  
Sleep Onset ◽  
Case Series ◽  
Upper Airway ◽  
Apnea Hypopnea Index ◽  
Cross Sectional ◽  
3 Dimensional ◽  
Surgical Success ◽  
Obstructive Sleep

Objective This study aims to evaluate the combination of genioglossus (GG) activity and anatomical characteristics in predicting outcomes of velopharyngeal surgery in patients with obstructive sleep apnea (OSA). Study Design Case series with planned data collection. Setting Sleep medical center. Subjects and Methods Forty patients with OSA underwent overnight polysomnography with synchronous genioglossus electromyography (GGEMG) using intraoral electrodes. The upper airway anatomy was evaluated by 3-dimensional computed tomography in patients with OSA. All patients received the same type of velopharyngeal surgery, consisting of revised uvulopalatopharyngoplasty with uvula preservation and concurrent transpalatal advancement pharyngoplasty. We followed up all patients using polysomnography for at least 3 months postoperatively. Results Twenty-five patients (62.50%) were responders, and 15 patients (37.50%) were nonresponders. The decreased apnea-hypopnea index was significantly positively correlated to the sleep onset GGEMG ( P = .006) but was negatively correlated to the change in GGEMG ( P = .013) and tonic GGEMG ( P = .018). Multiple regression analysis revealed that the minimal cross-sectional airway area at the velopharynx (VmCSA) (odds ratio [OR], 1.760; P = .019) and the sleep onset GGEMG (OR, 0.322; P = .043) were significant predictors for surgical outcomes. Combined the two predictors, the area under the ROC curve was 0.901 (OR, 0.789; P = .001) for surgical success, was more valuable than any one predictor. The area under the ROC curve with GGEMG was 0.843, VmCSA was 0.848. Conclusions The combination of sleep onset GGEMG and VmCSA can predict the outcome of velopharyngeal surgery in patients with OSA.

Upper Airway Stimulation Response in Older Adults with Moderate to Severe Obstructive Sleep Apnea

2019 ◽  
Vol 161 (4) ◽  
pp. 714-719 ◽  
Author(s):  
Kirk Withrow ◽  
Sean Evans ◽  
John Harwick ◽  
Eric Kezirian ◽  
Patrick Strollo
Keyword(s):  
Older Adults ◽  
Body Mass Index ◽  
Body Mass ◽  
Epworth Sleepiness Scale ◽  
Upper Airway ◽  
Apnea Hypopnea Index ◽  
Upper Airway Stimulation ◽  
Younger Adults ◽  
Obstructive Sleep ◽  
The Impact

Objective To evaluate the impact of age on safety, efficacy, and usage of upper airway stimulation (UAS). Study Design Multicenter observational study. Setting Thirteen US hospitals and 3 German hospitals. Subjects and Methods The ADHERE registry is a multicenter database enrolling patients undergoing UAS implantation from October 2016 to April 2018. Outcome measures included the Epworth Sleepiness Scale, apnea-hypopnea index (AHI), therapy usage, and complications. Data were segmented by age (<65 vs ≥65 years). Results Younger adults (n = 365) were a mean ± SD 52.7 ± 7.9 years old and 82% male, with a body mass index of 29.6 ± 3.8. Older adults (n = 235) were 71.1 ± 4.8 years old and 71% male, with a body mass index of 28.8 ± 3.8. Baseline AHI was similar (younger, 36.2 ± 15.9; older, 36.1 ± 14.8). Both groups had lower AHI at 12 months versus baseline ( P < .001), but the older group showed a greater reduction (7.6 ± 6.9 vs 11.9 ± 13.4, P = .01). The Epworth Sleepiness Scale score decreased from 12.3 ± 5.4 to 7.1 ± 4.8 ( P < .001) among younger adults and from 10.7 ± 5.7 to 6.3 ± 4.4 ( P < .001) among older adults. Usage was slightly higher among older adults (6.0 ± 2.0 vs 5.4 ± 2.1 hours/night, P = .02). Surgical time was similar between younger patients (2.4 ± 0.7 hours) and older patients (2.3 ± 0.7 hours, P = .40), with comparably low complications. Conclusion AHI reduction and therapy usage were found to be somewhat higher among patients aged ≥65 years who were treated with UAS. Surgical complications were low, in contrast to traditional sleep surgery.

scholarly journals Visualizing Telemetry Metrics From Upper-Airway Stimulation to Enhance Sleep Therapy Management

2020 ◽  
Author(s):  
Matheus Araujo ◽  
Kent Lee ◽  
Quan Ni ◽  
Jaideep Srivastava
Keyword(s):  
Airway Pressure ◽  
Positive Airway Pressure ◽  
Upper Airway ◽  
Apnea Hypopnea Index ◽  
Telemetry Data ◽  
Upper Airway Stimulation ◽  
Duration Of Therapy ◽  
Obstructive Sleep ◽  
Therapy Success

Abstract Upper-Airway Stimulation (UAS) therapy is an innovative alternative to Continuous Positive Airway Pressure (CPAP) treatment for patients with obstructive sleep apnea (OSA) and CPAP intolerance. Patients who have implanted a UAS device are responsible for activating and managing the therapy at home before sleep. Consistent nightly use is required for a reduced OSA burden, measured by the apnea-hypopnea index. Thus, understanding patient behavior and possible challenges to nightly use are crucial to therapy success. In this work, we present two novel visualizations to monitor telemetry data recorded by the UAS sleep remote. They provide doctors and sleep clinicians with detailed information to easily classify therapy use and sleep patterns. We also present how to show daily metrics such as hours of average usage, therapy intensity, and duration of therapy pauses, to identify optimal therapy settings and measure the long-term effectiveness of interventions.

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