bluuebunny/crossref_metadata_2025_split huggingface dataset:
461 Hypoglossal Nerve Stimulation: Effectiveness of Therapy for Treatment of Positional Obstructive Sleep Apnea
Authors: White Michelle , Stuewe Elena , Zacharias Rajesh , Grover Aarti , Wein Richard 
Published: May 2021

Abstract

Introduction
Hypoglossal nerve stimulation (HGNS) therapy is highly effective treatment for patients with moderate-severe obstructive sleep apnea (OSA). Positional OSA is considered when the apnea-hypopnea index (AHI) is at least twice as high in supine position compared with non-supine position. There are few studies in the literature investigating response to HGNS in patients with positional OSA.

Methods
Pre- and post-implant polysomnography (PSG) data was retrospectively reviewed in 46 patients who underwent HGNS at a large tertiary care center from November 2017 to March 2020. Supine and non-supine AHI were used to diagnose positional OSA on pre- and post-implant PSG. Pre-implant AHI was recorded from both in-lab PSG as well as home sleep tests, while post-implant AHI was based on in-lab hypoglossal nerve stimulator titration performed three months after device activation. Overall AHI pre- and post-implantation and absolute AHI reduction (pre-implant AHI – post-implant AHI) were evaluated. Basic demographic information including age, sex and BMI were also recorded.

Results
25/46 patients (54%) were diagnosed with positional OSA on pre-implant PSG. Patients with positional OSA had lower pre-implant overall AHI than patients without positional OSA (AHI 29.6 and 38.9, respectively, p&lt;0.05) and lower absolute AHI reduction than patients without positional OSA (18.2 and 26.7, respectively, p&lt;0.05). There were no statistically significant differences in BMI and post-implant overall AHI between these groups. 19/25 patients (76%) with pre-implant positional OSA had persistent positional OSA on post-implant PSG.

Conclusion
Patients with positional OSA prior to HGNS had lower pre-implant overall AHI and absolute AHI reduction than patients without positional OSA. However, post-implant overall AHI was comparable, suggesting similar benefit in HGNS therapy regardless of positional OSA diagnosis. HGNS does not appear to resolve positional OSA, given that 76% of patients with positional OSA pre-implantation had persistent positional OSA post-implantation. Positional OSA after HGNS should be recognized in patients with persistent symptoms or inability to tolerate higher device amplitudes, and treatment with combination therapy with positional device can be considered.
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465 Evaluating the Impact of Sleep Disordered Breathing on Adverse Cardiovascular Outcomes After Bariatric Surgery
Authors: Heinzinger Catherine , Chindamporn Pornprapa , Bena James , Wang Lu , Milinovich Alex , Kaw Roop , Kashyap Sangeeta , Cetin Derrick , Aminian Ali , Kempke Nancy , Foldvary-Schaefer Nancy , Aboussouan Loutfi , Mehra Reena 
Published: May 2021

Abstract

Introduction
Sleep disordered breathing (SDB), including obstructive sleep apnea (OSA) and obesity-associated sleep hypoventilation (OASH), has well-characterized adverse effects on the cardiovascular system and increases morbidity and mortality. Long-term impact on cardiovascular outcomes post-bariatric surgery, however, remains unclear. We hypothesize that patients with SDB have increased frequency of major adverse cardiovascular events (MACE) post-bariatric surgery than those without.

Methods
Patients undergoing polysomnography (PSG) prior to bariatric surgery at The Cleveland Clinic from 2011–2018 were retrospectively examined and followed up from date of last surgery to 2019, including the perioperative period. Primary predictors include moderate-severe OSA, i.e. apnea hypopnea index(AHI)&gt;15, and OASH, i.e. body mass index (BMI)≥30kg/m2 and either end-tidal CO2≥45mmHg or serum bicarbonate≥27mEq/L. MACE (coronary artery events, cerebrovascular events, heart failure or atrial fibrillation)-free probability was compared using hazard ratios estimated from Cox proportional hazards models on four groups: OASH with moderate-severe OSA (N=492), OASH-only (N=442), moderate-severe OSA-only (N=203), and a reference group without OASH or moderate-severe OSA (N=243). Multivariable Cox proportional hazards models adjusting for age, sex, BMI were fit on MACE survival. Analysis was performed based on an overall significance level of 0.05, using SAS software (version 9.4, Cary, NC).

Results
The sample comprised 1380 patients: age: 43.5±12 years, BMI: 49±9 kg/m2, 17.7% male, 63.7% White. Risk of MACE across the groups bordered significance (p=0.051). Compared to the reference group, the OASH with moderate-severe OSA group had higher risk of MACE (HR2.53, 95%CI:1.07–6.00,p=0.035). Patients with moderate-severe OSA had higher risk of MACE than those with AHI&lt;15 (HR1.94, 95%CI:1.20–3.13,p=0.007). Patients with severe OSA had higher risk of MACE than those AHI&lt;30 (HR2.01, 95%CI:1.28–3.14,p=0.002). For every 5-unit AHI increase, risk of MACE increased by 6% (HR1.056, 95%CI:1.029–1.084,p&lt;0.001) with slight reduction in point estimates in adjusted models.

Conclusion
Preliminary data from this largest-to-date sample of systematically phenotyped patients with SDB undergoing bariatric surgery show significant differences in risk of MACE and MACE-free survival mitigated after consideration of obesity. Further investigation to elucidate effect modification by obesity and metabolic factors is needed.

Support (if any)
Cleveland Clinic Transformative Resource Neuroscience Award
466 Transvenous Phrenic Nerve Stimulation for Central Sleep Apnea: A Systematic Review
Authors: Sagalow Emily , Ananth Ashwin , Fares Elie , Fast Zhanna 
Published: May 2021

Abstract

Introduction
RespiCardia™ remedē® System, a transvenous phrenic nerve stimulator, is indicated to treat central sleep apnea (CSA) in certain patients. CSA involves disruption of the normal breathing pattern during sleep; CSA is associated with decreased patient quality of life and worsens cardiovascular outcomes. Existing therapies for CSA are often complicated by poor patient adherence to therapy and occasional adverse effects. The remedē® System uses electrical stimulation of the phrenic nerve to cause diaphragmatic contraction and attempts to restore normal breathing during sleep.

Methods
Systematic review was conducted according to the Preferred Reporting of Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Databases were queried by two independent reviewers for English-language studies published between 2000 and 2020. The initial search screened for all occurrences of “remede” then was further refined to include studies evaluating use of the RespiCardia™ remedē® System as a treatment for CSA in multiple patients.

Results
Two hundred twenty-seven articles were identified from initial search results. Fourteen articles were identified through screening of title and abstracts from initial results. Seven additional articles were identified through reference review. Full-text review of all the articles was then completed. All articles were published after 2010. Of the 21 articles, a total of 1621 patients underwent device implantation. We sought to summarize the available evidence regarding patient selection for implantation, immediate and delayed complications, adherence to therapy, and polysomnographic evidence of efficacy.

Conclusion
The remedē® System has been demonstrated to improve sleep and respiratory parameters including AHI, CAI, arousal index, REM sleep, and ODI with few complications. This device proves to be a safe and effective treatment for moderate to severe CSA in adult patients, especially those with HF. Future studies examining long-term outcomes and delayed complications are needed.
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467 Positive Airway Pressure Tracking Systems: Outcomes of Polysomnographic Testing Prompted by the Residual Apnea Hyponea Index
Authors: Imtiaz Komal , Mathew Reeba , Nuzhny Valentin , Sargsyan Lilit , Majid Ruckshanda 
Published: May 2021

Abstract

Introduction
To assess positive airway pressure (PAP) adherence and efficacy, tracking systems have been developed to monitor hours of CPAP use, mask leak, and residual apnea-hypopnea index (AHI) while patients are on treatment. No formal guidelines however have been developed on how to interpret and utilize this information. We looked at treatment outcomes after an in-laboratory sleep study reevaluation was made based on clinical symptoms and the residual AHI.

Methods
We performed a retrospective chart review of adult patients evaluated with an in-laboratory polysomnogram (PSG) based on a clinical concern for inadequately treated obstructive sleep apnea (OSA) and the residual AHI obtained from the PAP tracking system. We documented the outcomes of the repeat study and follow-up AHI after the new intervention (if recommended). We excluded patients non-adherent to PAP.

Results
Nine patients were identified between January 2015 and 2020 at the McGovern Medical School Outpatient Sleep Clinic. All nine patients were male with an average age of 69.2 years (range 44–84). The average AHI on the diagnostic study (CMS criteria) was 37.1 events/hour (range 17.4–67.1). The average residual AHI prompting reevaluation was 9 events/hour (median 15.9). All patients had a change in treatment based on recommendations made after their sleep study. The clinical suspicion for central events on the tracking system was confirmed on PSG on three patients who were subsequently switched to adaptive servo-ventilation. Two patients were found to have central events without a previous suspicion for central events. Four were prescribed a higher pressure or BPAP for suspected untreated OSA confirmed on the repeat PSG. All of the patients had a decreased residual AHI (average 6.3 events/hour) after treatment changes were made.

Conclusion
Reevaluation with a PSG after concerns of the residual AHI led to a change in diagnosis (complex sleep apnea) or the need for higher treatment pressures in our cohort. This lead to the optimization of therapy and a decrease in AHI on the tracking system post-intervention, hence justifying the repeat PSG. Exact guidelines however need to be set to standardize the recommendations with a potential cut-off residual AHI after which a repeat PSG is the standard.
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469 Utilization of the STOP-Bang questionnaire for referral of obstructive sleep apnea in various geographical regions
Authors: Pivetta Bianca , Chen Lina , Nagappa Mahesh , Saripella Aparna , Waseem Rida , Englesakis Marina , Chung Frances 
Published: May 2021

Abstract

Introduction
Obstructive sleep apnea (OSA) is a highly prevalent global health concern and is associated with many adverse outcomes for patients. Our objective is to determine the utility of the STOP-Bang questionnaire in the sleep clinic setting to screen for and stratify the risk of OSA among populations from different geographical regions.

Methods
The following electronic databases were systematically searched from 2008 to March 2020: MEDLINE, Medline-in-process, Embase, EmCare Nursing, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, Journals @ Ovid, Web of Science, Scopus, and CINAHL. Inclusion criteria were: 1) assessment of the STOP-Bang questionnaire to screen for OSA in adult subjects (age ≥18 years); 2) patients referred to sleep clinic; 3) lab-polysomnography or home sleep apnea testing results confirmed the OSA diagnosis; and 4) apnea-hypopnea index (AHI) or respiratory disturbance index (RDI) was used to diagnose and grade the severity of OSA. Clinical and demographic data were extracted from each article independently by two reviewers (B.P., L.C.). Pooled predictive parameters were calculated using 2x2 contingency tables. Random effects meta-analyses and meta-regression with sensitivity analyses were performed. The Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) guidelines were followed.

Results
Forty-seven studies (n=26,547) studies met the criteria for systematic review (mean age: 49±14 years, mean body mass index: 32±8 kg/m2, 65% male). Studies were organized into different geographic regional groups – North America, South America, Europe, Middle East, East Asia, and South/Southeast Asia. The prevalence of all OSA, moderate-to-severe OSA, and severe OSA was 80%, 58%, and 39%, respectively. The area under the receiver operating curve of a STOP-Bang score ≥3 to detect moderate-to-severe OSA is high (&gt;0.80) in all regions, except in East Asia (0.52). A STOP-Bang score ≥ 3 has excellent sensitivity (&gt;90%) and high discriminative power to exclude moderate-to-severe, and severe OSA with negative predictive values of 77% and 91%, respectively.

Conclusion
The meta-regression analysis demonstrates that the STOP-Bang questionnaire can be utilized as an effective OSA screening tool among different geographical populations to assist in prioritizing patients with suspected OSA for assessment in sleep clinic.
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471 Identifying gaps in evaluation, treatment, and treatment adherence in women Veterans with sleep disordered breathing risk factors
Authors: Moghtaderi Isabel , Kelly Monica , Carlson Gwendolyn , Swistun Dominika , Fung Constance , Zeidler Michelle , Mitchell Michael , Josephson Karen , Lee Diane , Partch Lisa , Badr Safwan , Washington Donna , Yano Elizabeth , Alessi Cathy , Martin Jennifer 
Published: May 2021

Abstract

Introduction
In our recent national survey study, 13% of women Veterans reported a diagnosis of Sleep Disordered Breathing (SDB), of whom 65% used positive airway pressure (PAP) treatment. We also found many women Veterans at high risk for SDB were undiagnosed (43%). The current study builds upon this survey research to identify rates of evaluation, diagnosis, treatment, and treatment adherence among women Veterans with risk factors for SDB.

Methods
We analyzed telephone screening data from an ongoing SDB treatment adherence intervention study for women Veterans in Los Angeles county. A total of 173 women Veterans, identified by retrospective chart review as having at least one risk factor for SDB (i.e. high blood pressure, diabetes, obesity, depression, or &gt; 50 years old), completed the screener. Screening questions included 1) previous diagnostic testing for SDB, 2) SDB diagnosis 3) SDB treatment type, and 4) past week SDB treatment use. Descriptive statistics regarding evaluation and treatment of SDB are reported.

Results
In total, 31% of respondents endorsed having previously completed diagnostic testing, of whom, 54% reported an SDB diagnosis. Of those with diagnosed SDB, 82.8% were prescribed treatment (PAP [72.4%], oral appliance [6.9%], surgery [3.5%]), and 17.2% did not report being prescribed any SDB treatment. Of the 21 (72.4%) women Veterans diagnosed with SDB that were prescribed PAP, only 33% reported using treatment in the past week. Of the 2 women Veterans (6.9%) prescribed an oral appliance, 0% reported past week use.

Conclusion
Less than 1/3 of women Veterans with at least one risk factor for SDB had previously been evaluated for SDB; however, over 1/2 of women Veterans who were evaluated tested positive for SDB. Additionally, most women Veterans had not used PAP or oral appliance therapy in the past week. Greater clinical attention is needed to identify, evaluate, and diagnose SDB in women Veterans. Moreover, further research is needed to evaluate and inform interventions to address SDB treatment adherence barriers in women Veterans.

Support (if any)
VA HSR&D IIR 16–244 and RCS 20–191; NIH/NHLBI K24 HL143055, VAGLAHS GRECC and VA Office of Academic Affiliations.
472 Sleep Quality in Pregnancy: An Analysis of Cardiopulmonary Coupling in the nuMoM2b Cohort
Authors: Christian Francis , Hilmisson Hugi , magnusdottir Solveig , Thomas Robert 
Published: May 2021

Abstract

Introduction
The impact of pregnancy on sleep quality and sleep-breathing is of interest due to concerns of an impact on maternal, intra-uterine and neonatal health. The Sleep Disordered Breathing (SDB) sub-study of the Nulliparous Pregnancy Outcomes Study (NuMoM2b) provided a large cohort of single gestational women who underwent home sleep apnea testing (HSAT) to evaluate for SDB. To evaluate changes in sleep during pregnancy, we utilized publicly available data from http://www.sleepdata.org for cardiopulmonary coupling (CPC) analysis to evaluate SDB, as well as sleep duration and quality. No outcomes data is currently available.

Methods
Standardized Level 3 HSAT was performed after visit 1 (V1), (6–15 weeks’ gestation) and visit 3 (V3), (22 -31 weeks’ gestation) on 3702 women from the NuMoM2b cohort. CPC-analysis was performed using clinically validated algorithms based on CPC-method using ECG and oxygen saturation data (SpO2) as the input signals. SleepImage Apnea Hypopnea Index (sAHI) was calculated to evaluate for SDB (FDA; 182618). Additional calculations to determine sleep latency, sleep duration, wake after sleep onset, and sleep quality (SQI) were performed. The SQI-metric incorporates measures of sleep stability and instability and is then presented on a scale of 0 – 100 where a higher number is desirable.

Results
3,261 & 2,511 participants had data at visits 1 & 3, respectively. A total of 3,012 and 2,332 individuals had ECG data of sufficient quality. The mean age of the analyzed cohort was 27 years old. SDB events were overall low, but significantly increased across visits, sAHI [(1.6 ± 2.5)/hour (V1) vs (2.9 ± 4.1) (V3)], p&lt; 0.001. There was a statistically significant increase in sleep latency [7.4 ± 12.7 (V1) vs 18.7 ± 27.8 (V3)], p&lt; 0.001 and reduction in total sleep time [401.2 ± 85.6 (V1) vs 348.5 ± 79.3 (V3)], p&lt; 0.001. Most notably, there was a &gt;10% reduction in the SQI, indicative of increased unstable, fragmented sleep as pregnancy progressed [72.1 ± 13.8 (V1), 60.5 ± 16.2 (V3)], p &lt; 0.001.

Conclusion
Using objective measures based on CPC analysis from HSAT derived signals, sleep disordered breathing, sleep duration and sleep quality are all adversely impacted as gestation progresses.
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480 Cardiovascular and metabolic risk in patients with suspected comorbid insomnia and obstructive sleep apnea (COMISA)
Authors: e Cruz Miguel Meira , Seixas Luana , Santos Augusto , Garrido João , Lopes Yuri , Palombini Luciana , Gozal David , Galtieri Ranuzia , Salles Cristina 
Published: May 2021

Abstract

Introduction
Only few studies looked for a possible association of cardiovascular disorders (CVD), in comorbid insomnia with obstructive sleep apnea (COMISA) even though this is a relevant topic in order to prevent one of the major causes of morbimortality. The present study aimed to investigate the association of insomnia symptoms in patients at risk for obstructive sleep apnea in terms of prevalence and clinical interactions and to evaluate the risk of CVD in patients with a risk for COMISA.

Methods
This is a cross-sectional study. All medical records with data such as age, sex, height, weight and BMI, time to sleep, time to wake up, total sleep time, the Epworth Sleepiness Scale (ESS), STOP-BANG Questionnaires were studied. Insomnia and comorbidities were also investigated, and the patientsanswered yes or no to systemic arterial hypertension, diabetes, CVD.

Results
685 patients were enrolled on the present study. We observed that the mild, moderate, and high risk for COMISA presented progressively increasing levels for the frequency of hypertension, diabetes, and CVD. A binary logistic regression was performed to assess whether risk for COMISA could be a predictor for CVD, and it was found that the model containing risk for COMISA was statistically significant: [x2(1)=5.273;p&lt;0.021, R2 Negelkerke=0.014]. Risk for COMISA presented itself as a significant predictor for CVD (OR=1.672; 95% CI=1.079–2.592).

Conclusion
There was an increased frequency of associated comorbidities such as CVD, systemic arterial hypertension, and diabetes, according to the mild, moderate, or high risk. These findings highlight the need for a cardiometabolic evaluation in patients with this comorbid condition which may impact prognosis and therapeutic success.
Support (if any):
490 Efficacy of FT218 on Polysomnographic Measures of Sleep Continuity in Patients With Narcolepsy: Results From the REST-ON Trial
Authors: Dauvilliers Yves , Thorpy Michael , Roth Thomas , Rosenberg Russell , Corser Bruce , Shapiro Colin , Ajayi Akinyemi , Dubow Jordan , Seiden David , Kushida Clete 
Published: May 2021

Abstract

Introduction
Disturbed nocturnal sleep (DNS) is a common symptom in patients with narcolepsy, characterized by fragmented sleep, including frequent brief nightly awakenings. Sodium oxybate (SO) is an effective treatment for narcolepsy; however, currently available formulations must be taken twice nightly. FT218 is an investigational once-nightly controlled-release formulation of SO. Here, we evaluated the efficacy of FT218 on polysomnographic (PSG) measures of DNS and number of arousals (NAs) in patients with narcolepsy types 1 and 2.

Methods
This was a randomized, double-blind, placebo-controlled, multicenter study. Patients with narcolepsy aged ≥16 years were randomized 1:1 to receive FT218 or matching placebo: 4.5 g/night for 1 week, 6.0 g/night for 2 weeks, 7.5 g/night for 5 weeks, and 9.0 g/night for 5 weeks. Secondary endpoints included PSG measurements of DNS (defined as shifts to wake/N1 from N1, N2, N3, and REM) and NAs (defined per AASM Scoring Manual guidelines [v2.6]).

Results
Patients receiving FT218 had significant improvements vs placebo in DNS; the LS mean difference between FT218 and placebo was −22.63 for 9.0 g (week 13), −17.70 for 7.5 g (week 8), and −11.00 for 6.0 g (week 3) (all P&lt;0.001). Patients receiving FT218 also had significant reduction in number of NAs vs placebo; the LS mean difference between FT218 and placebo for NAs was −23.68 (P&lt;0.001) for 9.0 g, −19.41 (P&lt;0.001) for 7.5 g, and −11.29 (P=0.021) for 6.0 g. The most common adverse reactions were nausea, dizziness, enuresis, headache, decreased appetite, and vomiting.

Conclusion
FT218 at all evaluated doses showed significant reduction in DNS and number of NAs vs placebo for all doses of FT218 evaluated. FT218 was generally well tolerated; the most common adverse events were consistent with known SO side effects. FT218 could offer a new once-nightly treatment option for DNS in patients with narcolepsy as demonstrated by PSG measures.

Support (if any)
Avadel Pharmaceuticals.