scholarly journals 0676 Long-term Effects Of Upper Airway Stimulation For Treatment Of Obstructive Sleep Apnea On Measurements Of Central And Mixed Apneas

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A258-A258
Author(s):  
S A Myers ◽  
K M Sundar ◽  
P J Strollo
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Upper Airway ◽  
Phase Iii ◽  
Apnea Hypopnea Index ◽  
Medical Systems ◽  
Long Term Effects ◽  
Upper Airway Stimulation ◽  
Obstructive Sleep

Abstract Introduction Upper airway stimulation (UAS) of the hypoglossal nerve for obstructive sleep apnea (OSA) is well-tolerated and results in sustained reduction in the apnea-hypopnea index (AHI). Treatment-emergent CSA is reported to occur in 3.5-19.8% of OSA patients treated with CPAP. We aimed to examine the occurrence or emergence of central and mixed apneas in a cohort of participants that received UAS and were followed for 5 years post implantation. Methods The Stimulation Trial for Apnea Reduction (STAR) was a Phase III trial evaluating the safety and efficacy of UAS for CPAP-intolerant OSA. Major inclusion criteria were CPAP intolerance, AHI between 20-50, less than 25% central and mixed apneas and BMI <= 32. Polysomnography was performed at baseline, 12, 18, 36 and 60-month follow-up. Data were scored by a core lab and was then retrospectively analyzed via the STAR PSG database to measure the evolution of central and mixed apneas on UAS therapy. Results Baseline age was 54.5 ± 10.2 years, BMI was 28.4 ± 2.6 kg/m2 and 83% male (n=126). AHI data were non-normally distributed. Median AHI was 29.3/hr at baseline, that was reduced to 9/hr at 12-months and 6/hr at 60-months. Median central apnea index (CAI) was 0.8/hr at baseline, 0.4/hr at 12-months, and 0.2/hr at 60-months. Median mixed apnea index (MAI) was 0.2/hr at baseline, 0.7/hr at 12-months and 0.4/hr at 60-months. The 12- and 60-month CAI was significantly lower than baseline (p<0.05), but MAI was not. The percentage of central and mixed events remained stable throughout follow-up, approximately at 5% of the total AHI. Conclusion UAS reduced the overall AHI and results in a small but significant decrease in CAI. Given that OSA and CSA frequently co-exist, the role of UAS on reducing CSA in patients with combined OSA and CSA deserves further investigation. Support STAR study was sponsored by Inspire Medical Systems

Obstructive Sleep Apnea in Acromegaly and the Effect of Treatment: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 105 (3) ◽  
pp. e23-e31 ◽  
Author(s):  
Matteo Parolin ◽  
Francesca Dassie ◽  
Luigi Alessio ◽  
Alexandra Wennberg ◽  
Marco Rossato ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Meta Analysis ◽  
Upper Airway ◽  
Apnea Hypopnea Index ◽  
Cross Sectional ◽  
Obstructive Sleep ◽  
Before And After ◽  
The Difference

Abstract Background Obstructive sleep apnea (OSA) is a common disorder characterized by upper airway collapse requiring nocturnal ventilatory assistance. Multiple studies have investigated the relationship between acromegaly and OSA, reporting discordant results. Aim To conduct a meta-analysis on the risk for OSA in acromegaly, and in particular to assess the role of disease activity and the effect of treatments. Methods and Study Selection A search through literature databases retrieved 21 articles for a total of 24 studies (n = 734). Selected outcomes were OSA prevalence and apnea-hypopnea index (AHI) in studies comparing acromegalic patients with active (ACT) vs inactive (INACT) disease and pretreatment and posttreatment measures. Factors used for moderator and meta-regression analysis included the percentage of patients with severe OSA, patient sex, age, body mass index, levels of insulin-like growth factor 1, disease duration and follow-up, and therapy. Results OSA prevalence was similar in patients with acromegaly who had ACT and INACT disease (ES = −0.16; 95% CI, −0.47 to 0.15; number of studies [k] = 10; P = 0.32). In addition, AHI was similar in ACT and INACT acromegaly patients (ES = −0.03; 95% CI, −0.49 to 0.43; k = 6; P = 0.89). When AHI was compared before and after treatment in patients with acromegaly (median follow-up of 6 months), a significant improvement was observed after treatment (ES = −0.36; 95% CI, −0.49 to −0.23; k = 10; P < 0.0001). In moderator analysis, the percentage of patients with severe OSA in the populations significantly influenced the difference in OSA prevalence (P = 0.038) and AHI (P = 0.04) in ACT vs INACT patients. Conclusion Prevalence of OSA and AHI is similar in ACT and INACT patients in cross-sectional studies. However, when AHI was measured longitudinally before and after treatment, a significant improvement was observed after treatment.

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.

Long-term follow-up of the German post-market study for upper airway stimulation for obstructive sleep apnea

2019 ◽  
Vol 24 (3) ◽  
pp. 979-984 ◽  
Author(s):  
Armin Steffen ◽  
Ulrich J. Sommer ◽  
Joachim T. Maurer ◽  
Nils Abrams ◽  
Benedikt Hofauer ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Upper Airway ◽  
Upper Airway Stimulation ◽  
Obstructive Sleep ◽  
Post Market ◽  
Long Term Follow Up

Adjustable Tongue Advancement for Obstructive Sleep Apnea: A Pilot Study

2008 ◽  
Vol 117 (11) ◽  
pp. 815-823 ◽  
Author(s):  
Evert Hamans ◽  
An Boudewyns ◽  
Boris A. Stuck ◽  
Alexander Baisch ◽  
Marc Willemen ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Positive Airway Pressure ◽  
Upper Airway ◽  
Apnea Hypopnea Index ◽  
Obstructive Sleep ◽  
Clinical Adverse Event ◽  
The Mean ◽  
Substantial Morbidity

Objectives: Surgical treatment of obstructive sleep apnea (OSA) caused by hypopharyngeal collapse of the upper airway can be considered in patients who are intolerant to continuous positive airway pressure (CPAP). The present procedures addressing the hypopharynx are invasive and have substantial morbidity and limited efficacy. Methods: Ten patients (mean age, 44 years) with moderate to severe OSA, ie, an apnea-hypopnea index (AHI) between 15 and 50, with CPAP intolerance were included in a prospective, nonrandomized, multicenter study to evaluate the feasibility, safety, and efficacy of a novel tongue advancement procedure. The procedure consists of the implantation of a tissue anchor in the tongue base and an adjustment spool at the mandible. Titration of this tissue anchor results in advancement of the tongue and a patent upper airway. Results: The mean AHI decreased from 22.8 at baseline to 11.8 at the 6-month follow-up (p = 0.007). The Epworth Sleepiness Scale score decreased from 11.4 at baseline to 7.7 at the 6-month follow-up (p = 0.094), and the snoring score decreased from 7.5 at baseline to 3.9 at the 6-month follow-up (p = 0.005). Four technical adverse events were noted, and 1 clinical adverse event occurred. Conclusions: Adjustable tongue advancement is a feasible and relatively safe way to reduce the AHI and snoring in selected patients with moderate to severe OSA and CPAP intolerance. Technical improvements and refinements to the procedure are ongoing.

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.

scholarly journals 0576 SELECTIVE UPPER AIRWAY STIMULATION IN OBSTRUCTIVE SLEEP APNEA: GERMAN POST MARKET STUDY - 12 MONTHS FOLLOW-UP

SLEEP ◽  
2017 ◽  
Vol 40 (suppl_1) ◽  
pp. A214-A214
Author(s):  
C Heiser ◽  
JT Maurer ◽  
B Hofauer ◽  
JU Sommer ◽  
A Seitz ◽  
...  
Keyword(s):  
Obstructive Sleep Apnea ◽  
Sleep Apnea ◽  
Upper Airway ◽  
Upper Airway Stimulation ◽  
Obstructive Sleep ◽  
Post Market
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