scholarly journals What makes the responder to upper airway stimulation in obstructive sleep apnea patients with positive airway pressure failure?

2018 ◽  
Vol 10 (S26) ◽  
pp. S3131-S3134 ◽  
Author(s):  
Armin Steffen
SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A262-A262
Author(s):  
R Bhambra ◽  
M Pascoe ◽  
A Kominsky ◽  
R Mehra ◽  
J Aylor ◽  
...  

Abstract Introduction Upper Airway Stimulation (UAS) is increasingly being used for obstructive sleep apnea (OSA) treatment, however, data comparing changes in patient reported outcomes (PROs) in response to positive airway pressure (PAP) versus UAS are limited. We hypothesize that there will be no difference in PROs between the two groups after treatment. Methods UAS and PAP groups were 1:3 matched on age, sex, Body Mass Index (BMI) and Apnea Hypopnea Index (AHI, category 15-30, >30). Linear mixed models assessed the difference of change in Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), Patient Health Questionnaire (PHQ9) and Insomnia Severity Index (ISI) measures on matched strata of UAS versus PAP groups with adjustment of baseline and matching factors. All analysis was performed in SAS software (version 9.4, Cary, NC). Results The analytic sample comprised 193 PAP patients and 69 UAS patients, with mean age=62.9+/-9.4 years, 27.5% female, mean BMI=29.1+/-3.2kg/m2, and median AHI 42.7, IQR: 31.5, 57.2. ESS in PAP (n=190) reduced by -2.63 (-3.38,-1.88) and in UAS (n=56) reduced by -2.22 (-3.34, -1.10), with a mean difference of 0.41 (-0.70, 1.52, p=.46). FOSQ in PAP (n=188) showed a change of 1.38 (0.99, 1.78) and in UAS (n=49) a change of 1.82 (1.17, 2.46), with a mean difference of 0.43 (-0.23, 1.09, p=.19). PHQ9 in PAP (n=185) showed a significant change of -2.24(-3.00, 1.47) and in UAS (n=45) a change of -3.75(-5.07,-2.42), with a mean difference of -1.51(-2.93,-0.088, p=.038). ISI in PAP (n=193) showed a significant change of -3.20(-4.39,-2.02) and in UAS (n=47) a change of -4.83(-6.77,-2.90), with a mean difference of -1.63(-3.62, 0.37, p=.11). Conclusion Similar improvements in PROs were observed in both UAS and PAP patient groups, however UAS appeared to confer greater benefit in depressive symptoms relative to PAP. Randomized clinical trials should be designed to confirm these findings. Support N/A


2018 ◽  
Vol 159 (1) ◽  
pp. 194-202 ◽  
Author(s):  
B. Tucker Woodson ◽  
Kingman P. Strohl ◽  
Ryan J. Soose ◽  
M. Boyd Gillespie ◽  
Joachim T. Maurer ◽  
...  

Objective To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant. Study Design A multicenter prospective cohort study. Setting Industry-supported multicenter academic and clinical trial. Methods From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index <32 kg/m2, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring. Results Patients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI <20 events per hour and >50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients. Conclusions Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure.


SLEEP ◽  
2019 ◽  
Vol 42 (6) ◽  
Author(s):  
A Simon Carney ◽  
Nick A Antic ◽  
Peter G Catcheside ◽  
Ching Li Chai-Coetzer ◽  
Peter A Cistulli ◽  
...  

Abstract Study Objectives Obstructive sleep apnea (OSA) is a serious and costly public health problem. The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients. Upper airway reconstructive surgery is available when medical treatments fail but randomized trial evidence supporting its use is limited. This protocol details a randomized controlled trial designed to assess the clinical effectiveness, safety, and cost-effectiveness of a multilevel upper airway surgical procedure for OSA. Methods A prospective, parallel-group, open label, randomized, controlled, multicenter clinical trial in adults with moderate or severe OSA who have failed or refused medical therapies. Six clinical sites in Australia randomly allocated participants in a 1:1 ratio to receive either an upper airway surgical procedure consisting of a modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction, or to continue with ongoing medical management, and followed them for 6 months. Results Primary outcomes: difference between groups in baseline-adjusted 6 month OSA severity (apnea–hypopnea index) and subjective sleepiness (Epworth Sleepiness Scale). Secondary outcomes: other OSA symptoms (e.g. snoring and objective sleepiness), other polysomnography parameters (e.g. arousal index and 4% oxygen desaturation index), quality of life, 24 hr ambulatory blood pressure, adverse events, and adherence to ongoing medical therapies (medical group). Conclusions The Sleep Apnea Multilevel Surgery (SAMS) trial is of global public health importance for testing the effectiveness and safety of a multilevel surgical procedure for patients with OSA who have failed medical treatment. Clinical Trial Registration Multilevel airway surgery in patients with moderate-severe Obstructive Sleep Apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true Australian New Zealand Clinical Trials Registry ACTRN12614000338662, prospectively registered on 31 March 2014.


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