bluuebunny/crossref_metadata_2025_split huggingface dataset:
0493 A new perspective on exploring the predictive factors of blood pressure reduction during CPAP treatment in OSA
Authors: Sun Bo , Shen Jiani , Yang Ting , Meng Zili , Xu Jing 
Published: May 2023

Abstract

Introduction
The predictive factors of BP response to continuous positive airway pressure (CPAP) in obstructive sleep apnea (OSA) are still being explored. We aimed to assess the antihypertensive effect of CPAP considering the obstructive respiratory event-triggered BP surge profiles in 130 subjects with severe OSA and untreated hypertension.

Methods
Nocturnal BP was monitored continuously and synchronized with polysomnography. Event-triggered BP surge profiles were studied: BP surge as the value of event-related systolic BP elevation; BP index as the number of BP surge events of ≥10 mmHg per hour. Patients were then divided into two groups according to the median BP index (high and low BP surge groups) and assigned to 4 weeks of CPAP. Changes in BPs and plasma biomarkers were compared. After the initial evaluation, patients with a better BP response in the high BP surge group were then followed up for the second evaluation at 24 months.

Results
Overall, a modest decrease was observed in both office and asleep BPs at the 4-week follow-up; however, BPs dropped more markedly in patients in high BP surge group than those in low BP surge group, in both office systolic BP (SBP:5.3 mmHg vs.2.2 mmHg, P=.005) and diastolic (DBP:4.0mmHg vs.1.2 mmHg, P=.011), especially the asleep SBP (9.0mmHg vs.2.1 mmHg, P&lt;.001). For 30 cases in the high BP surge group, optimal BP control was achieved in 60.0% of patients and BP &lt; 140/90mmHg reached up to 83.3% after 24 months of CPAP. Linear regression revealed that BP index was significantly associated with BP decrease during CPAP treatment.

Conclusion
Our results suggest that high event-triggered BP surge was a sensitive predictor of BP response to CPAP in patients with severe OSA and hypertension.

Support (if any)
0509 Adverse Event Reports for CPAP, HNS and Oral Devices: An FDA MAUDE Database Analysis
Authors: Liptak Len , Murphy Mark 
Published: May 2023

Abstract

Introduction
This investigation analyzes adverse event reports (AERs) from the FDA MAUDE database for Continuous Positive Airway Pressure (CPAP), Hypoglossal Nerve Stimulation (HNS) and Oral Appliance Therapy (OAT) devices. The FDA defines adverse events as undesirable experiences associated with medical devices that should be reported when the outcome is death, life threatening, hospitalization, disability, required intervention, or serious medical events.

Methods
Publicly available industry reports were utilized to estimate prevalence of AERs.

Results
From January 1, 2022 to September 2022, AERs for CPAP, HNS and OAT were 72,251, 11,867 and 30, respectively. From January 2017 to September 2022, the annual count of AERs for CPAP and HNS increased 245% and 252% respectively. The annual count of AERs for OATs decreased -1.3% over the same period. Device Problems For CPAP, “Degradation” comprised 96.6% of the AERs. For HNS, “Event Without Problem” and “Device Sensing” comprised 78.6% and 11.0% of AERs respectively. For OAT “Event without Identification” and “Breakage” comprised 40.0% and 9.8% of AERs respectively. Patient Problems For CPAP, seven patient problems comprise over 80% of reports: No Clinical Signs/Conditions, 57.3%; Dyspnea, 5.4%; Headache, 5.3%; Sore Throat, 4.3%; Respiratory Tract Infection, 4.1%; Cough, 3.5%; Unspecified Respiratory, 3.0%. For HNS, nine patient problems comprise over 80% of reports: Unspecified Infection, 19%; Pain, 15.2%; No Clinical Conditions, 9.2%; Bacteria Infection, 8.7%; Perforation of Vessels, 7.1%; Erosion, 7.1%; Wound Dehiscence, 4.9%; Swelling/Edema, 4.8%; Hematoma, 4.4%. For OAT, seven patient problems comprise over 80% of reports: Hypersensitivity/Allergic Reaction, 23.5%; Reaction, 19.0%; No Known Impact, 15.9%; Swelling, 8.7%; Pain, 6.2%; Discomfort, 4.5%; Erythema, 3.8%; Rash, 3.5%.

Conclusion
This analysis suggests that healthcare providers may wish to consider the significant differences in the frequencies and the severities of adverse events when prescribing treatment modalities for patients with OSA. Dental side effects, a widely referenced reason for limiting the utilization of OAT devices, do not show up in the top 80% of the most frequently reported types of adverse events.

Support (if any)
0511 An observational retrospective study of the efficacy of oral appliance therapy (OAT) in treating obstructive sleep apnea (OSA)
Authors: Meskill Sarah , Rege Riddhi , Kincheloe Kelly , Meskill Gerard 
Published: May 2023

Abstract

Introduction
Obstructive sleep apnea (OSA) affects approximately 15-30% of males and 10-15% of females in North America. While positive airway pressure (PAP) therapy remains the standard in the treatment of OSA, oral appliance therapy (OAT) has emerged as a viable non-invasive alternative. However, there are limited data on OAT efficacy published, and therefore many sleep clinicians question its efficacy. We conducted a 14-month single-center consecutive chart review to evaluate OAT efficacy.

Methods
A manual chart review was performed for records from 11/1/2020 to 12/10/2022. Potential charts were identified in the electronic health record by searching for prescriptions for OAT and orders for home sleep apnea tests (HSAT). If there was a test performed after the prescription was written, the chart was reviewed manually for previous test results and verified that post-OAT testing was conducted. Extracted information included age, BMI, gender, pre-OAT HSAT apnea-hypopnea index (AHI), and post-OAT HSAT AHI. The 4% desaturation criteria for AHI was used in accordance with current Medicare guidelines. A paired t-test was performed after ensuring there were no outliers and a normal distribution.

Results
There were 10 patients included in the analysis: 6 women, 4 men. The average age was 61.1 years (95% CI 49.9-72.3), and average BMI was 28.9 (95% CI 253-32.4). Prior to intervention, 2 patients had moderate OSA with the rest mild (average pre-OAT AHI 13). After OAT device, 4 patients had mild OSA and the rest did not have residual OSA (average post-OAT AHI 4). The results of the paired t-test showed that the mean AHI was statistically significantly different between the two groups (t=-4.54 with df=9, p=0.0014). The mean difference was -8.1 with 95% confidence interval for the true difference in the population mean AHI of -12.1, -4.06.

Conclusion
The results demonstrate efficacy of OAT in treating OSA. Clinicians should consider OAT as both primary and secondary therapy for mild-to-moderate OSA.

Support (if any)
N/A
0512 Apnea-Hypopnea Index does not correlate with Non-Alcoholic Fatty Liver Disease scores
Authors: Vacheron Albert , Saha Anand , Coughlin Kevin , Freire A X , Theus Sue 
Published: May 2023

Abstract

Introduction
Obstructive Sleep Apnea (OSA) and Nonalcoholic Fatty Liver Disease (NAFLD) are two conditions that have increased in prevalence in the United States. NAFLD is a spectrum of liver disease ranging from steatosis to non-alcoholic steatohepatitis (NASH) to cirrhosis. The purpose of this project is to study the relationship between OSA, measured by apnea-hypopnea index and/or arterial oxygen saturation nadir (O2 nadir) during sleep (independent variable) vs. extent of NAFLD as measured by non-invasive scores such as NAFLD Fibrosis score, aminotransferase to platelet ratio index (APRI), BARD score and FIB-4 score (dependent variable).

Methods
A convenient sample of 91 haphazardly selected veterans with OSA and NAFLD from the Veterans Affairs (VA) Computerized Record System (CPRS) system were included in the study. NAFLD eligibility was determined by abdominal ultrasound, CT scan, MRI, or biopsy. Dependent variables were NAFLD scores of APRI, NAFLD Fibrosis, BARD, and FIB-4. OSA was determined by in-lab polysomnogram or home sleep study. Independent variables were AHI, O2 nadir, age and body mass index (BMI). Patients with a history of alcohol abuse or Hepatitis B or C were excluded from the study. A multiple regression analysis was used to describe the relationship between OSA and NAFLD scores. P&lt; 0.05 was considered statistically significant.

Results
Age correlated with FIB-4 score, BARD score, and NAFLD fibrosis score (p = &lt; 0.001, 0.003, &lt; 0.001, respectively). BMI correlated with NAFLD fibrosis score (p &lt; 0.001). When controlled for age and BMI, AHI and O2 nadir did not correlate with APRI, NAFLD fibrosis, BARD, or FIB-4 scores.

Conclusion
OSA measured by AHI and O2 nadir do not correlate with severity of fatty liver disease as measured by APRI, NAFLD fibrosis, BARD, or FIB-4 scores.

Support (if any)
None
0513 Assessing precision oral appliance efficacy using frequency- and risk-based indices
Authors: Mosca Erin , Grosse Joshua , Jahromi Seyed Abdolali Zareian , Remmers John 
Published: May 2023

Abstract

Introduction
Apnea-hypopnea index (AHI), a frequency-based index commonly used to define the severity of obstructive sleep apnea (OSA), fails to capture the risk related to OSA. Sleep apnea-specific hypoxic burden (SASHB) appears to be more predictive of OSA-related risk than AHI but has only been studied in cohorts of untreated individuals. This is the first assessment of the ability of precision oral appliance therapy (OAT) to reduce SASHB and the use of SASHB, rather than AHI, to define therapeutic efficacy.

Methods
Data previously obtained from a clinical study investigating prediction of response to precision OAT in OSA were analyzed. Study participants with OSA (n = 11 mild, n = 19 moderate, and n = 18 severe) completed two-night level 3 home sleep tests before and after receiving a precision oral appliance (ProSomnus Sleep Technologies, Pleasanton, CA). Apnea-hypopnea index and SASHB were calculated. For SASHB, a cut-off of 53 %min/h was selected based on data suggesting that values above this limit are associated with OSA-related risk; for AHI, cut-offs of &lt; 10 h-1 and &lt; 15 h-1 were selected due to their widespread use in clinical practice.

Results
Precision oral appliance therapy reduced AHI from 31.6 ± 19.2 h-1 to 11.7 ± 15.8 h-1 (p &lt; 0.001) and SASHB from 83.2 ± 63.6 %min/h to 25.2 ± 42.3 %min/h (p &lt; 0.001). Using an AHI-based definition of therapeutic efficacy, 83% (for AHI &lt; 15 h-1) and 71% (for AHI &lt; 10 h-1) of participants achieved efficacy with precision OAT. However, when the risk-based SASHB definition of therapeutic efficacy (SASHB &lt; 53 %min/h) was used, precision OAT efficacy increased to 90%.

Conclusion
In the population studied, precision OAT significantly improved SASHB. The use of AHI, a frequency-based index of OSA, appears to misclassify some individuals as therapeutic non-responders to precision OAT despite their having an SASHB in the low-risk range. Sleep apnea-specific hypoxic burden likely provides a more meaningful assessment of OSA treatment efficacy as it accounts for the risk associated with the disease.

Support (if any)
This work was supported by ProSomnus Sleep Technologies.
0530 Efficacy of obstructive sleep apnea treatment by a unique oral appliance and effect of concurrent myofunctional and CPAP therapy
Authors: Lee-Heidenreich David , Heckman Seth , Kushida Clete 
Published: May 2023

Abstract

Introduction
Current treatment options for obstructive sleep apnea (OSA) include positive airway pressure, oral appliances, and upper airway surgery. The Day and Night Appliance (DNA) is a component of a dentist-guided system (Complete Airway Repositioning and Expansion [CARE], Vivos Therapeutics) that leads to gradual increases in upper airway volume. This study examines the effects of DNA treatment on OSA in patients before and after use of the device; we also examined how DNA treatment was impacted by concurrent myofunctional and CPAP therapy.

Methods
Data from a prospectively-collected clinical database (Vivos Airway Intelligence Service [AIS]) were reviewed, and 94 adult OSA patients who met DNA use criteria and had pre- and post-treatment sleep studies without the device in place were included. We compared the apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) pre- and post-treatment using a paired t-test and fit linear regression models with change in AHI and ODI as dependent variables.

Results
Mean patient age was 47.8±14.7 years and 44.7% were men. Pre- and post-treatment sleep studies were conducted 15.2±7.0 months apart. 24.5% of patients were treated with DNA and myofunctional therapy (14.1% exclusively myofunctional, 10.4% myofunctional plus another treatment, e.g., tonsillectomy, frenectomy). 17.0% of patients were treated with CPAP (12.8% exclusively CPAP, 4.2% CPAP plus another treatment). For both pre-treatment and post-treatment, mean AHIs were 22.3±19.4 and 12.7±11.2 respectively (p&lt; 0.0001) and mean ODIs were 11.6±13.7 and 7.8±9.1 respectively (p&lt; 0.0001). Excluding patients who had undergone myofunctional therapy and another treatment modality and adjusting for patient age, BMI, and gender, we found myofunctional therapy was associated with a -10.4 change in AHI (p=0.038). However, myofunctional therapy was not associated with a significant change in ODI (p=0.905). Concurrent CPAP use did not have a significant association with change in either AHI (p=0.47) or ODI (p=0.61).

Conclusion
This study shows that DNA use significantly improved post-treatment OSA severity, and that concurrent myofunctional but not CPAP therapy may result in further OSA improvement. An oral appliance system that provides palatal expansion with consequent improvement in OSA severity but does not require permanent nightly use has advantages over conventional oral appliances; however, further investigation is warranted.

Support (if any)
0538 Mariposa: Oral Therapy AD109 Improves Objective & Patient Reported Outcomes In OSA. Randomized, Placebo Controlled Clinical Trial
Authors: Ojile Joseph , Schweitzer Paula , Thein Stephen , Drake Christopher , Rosenberg Russell , Corser Bruce , Abaluck Brian , Sangal Bart , Maynard James 
Published: May 2023

Abstract

Introduction
Obstructive sleep apnea (OSA) is a common disorder with often poorly tolerated treatment . While there is currently no approved pharmacotherapy for OSA, the combination of noradrenergic and antimuscarinic drugs, counteracting sleep-related upper airway muscle hypotonia, has recently shown encouraging results. AD109 is a combination of the norepinephrine reuptake inhibitor atomoxetine and the antimuscarinic aroxybutynin, the R-enantiomer of oxybutynin which recently showed efficacy over 1-night treatment in mild OSA patients. Safety and efficacy data over longer periods and in more severe OSA patients are needed.

Methods
Mariposa was a 25-center, randomized, controlled, parallel arms clinical trial designed to evaluate efficacy, safety, and tolerability vs placebo of 2 doses of AD109 (75/2.5mg and 75/5mg) and atomoxetine 75mg alone administered for 4 weeks in OSA patients with an apnea-hypopnea index (AHI4, 4% desaturation definition for hypopneas) between 10 and 45. The primary outcome was the change in AHI4, AD109 vs. placebo. Patient reported outcome questionnaires (PROMIS) were studied as exploratory outcomes.

Results
211 patients (41% female) with median (IQR) age 55 (48-60) years and BMI 32.2 (28.0-35.2) kg/m2 were randomized. AHI4 was reduced from 20.5 (12.3-27.2) to 10.8 (5.6-18.5) in the AD109 75/2.5mg dose arm and from 19.4 (13.7-26.4) to 9.5 (6.1-19.3) in the 75/5mg arm (both p&lt; 0.0001 vs placebo). AHI4 was reduced from 19.0 (11.8-28.8) to 11.8 (5.5-21.5) with atomoxetine alone (p&lt; 0.01 vs placebo) and from 20.1 (11.9-25.9) to 16.3 (11.1-28.9) on placebo. Overall, 44% had a reduction from baseline greater than 50% when treated with AD109. On AD109 75/2.5 dose, there was an improvement of PROMIS fatigue scores (p&lt; 0.05 vs placebo and atomoxetine alone). Despite improving AHI4, atomoxetine alone reduced by 20+ minutes total sleep time vs placebo and AD109 (p&lt; 0.05). There were no severe adverse events on AD109 with the most common side effects being dry mouth, insomnia, and nausea.

Conclusion
AD109 objectively and subjectively improved OSA severity in a group of patients with a wide range of AHI4 over 4 weeks of treatment. Results from the Mariposa trial are central for the design of phase 3 trials of AD109 in OSA.

Support (if any)
This study was supported by Apnimed.
0539 OAT Device Designs Are Not the Same When it Comes to FDA Adverse Event Reports
Authors: Murphy Mark , Rohatgi Rose , Liptak Len 
Published: May 2023

Abstract

Introduction
This investigation analyzes whether differences in OAT device designs are associated with different frequencies of adverse event reports (AERs).

Methods
Each AER identifies the OAT device used by the patient. Each OAT device was characterized using public information. Investigators utilized data from public sources, such as Frost & Sullivan, to estimate prevalence.

Results
Most frequently reported events were: allergic, swelling, rash and Pain/Discomfort. Only 2.5% of AERs pertained to dental side effects (tooth movements, bite changes). 98.5% of AERs involved OATs made from Lab Materials (acrylics, thermoformed polymers, nylons). 1.5% of AERs involved OATs made from engineered PMMA or Medical Grade Class VI polymers. OATs with Lab Formed materials were an estimated 22.6 times more likely to have an AER than those with Engineered Materials. Components (Herbsts, clasps, screws) comprised 55.6% of AERs. Elastomeric/Nylon Components (straps, bands, rods) comprised 42.4% of AERs. OATs with Monolithic Structures (no components) accounted for 2.0% of AERs. Compared with monolithic OATs, OATs using Metal Components and OATs using Elastomeric/Nylon components were 18.2 and 13.9 times more likely to have an AER. Anterior Clasps Mechanisms, Push Herbsts, Pull straps, bands, rods, 70-Degree Posts, and 90-Degree Twin Posts accounted for 45%, 42.7%, 6.1%, 5.6% and 0.6% of AERs respectively. Compared with 90-Degree Twin Post Mechanisms, Push mechanisms and OATs with Pull Mechanisms were 154 times and 146 times more likely to have an AER. Lab Formed OATs with Liners, Lab Formed Linerless OATs and Precision Engineered Linerless OAT devices accounted for 77.3%, 21.2% and 1.5% of events reported, respectively. OATs with Liners were an estimated 35.5 times more likely to have an AER than Precision Engineered Linerless OATs.

Conclusion
All OAT device designs are not the same when it comes to AERs. More AERs are associated with reactions. Dental side effects infrequently result in AERs. OAT devices that use Precision Engineered Materials, Monolithic Structures, 90-Degree Twin Posts and Precision Engineered Linerless designs are associated with lower frequencies of AERs. The results of this investigation suggest that medical guidelines and insurance coding should empower therapy providers with the flexibility to prescribe devices that are associated with fewer AERs.

Support (if any)
0542 Obstructive sleep apnea in outpatients with COPD at Can Tho University of Medicine and Pharmacy Hospital – An Observational Study
Authors: Pham Thu Vo 
Published: May 2023

Abstract

Introduction
The concurrence of obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD) is generally identified as overlap syndrome.This study evaluated biometric characteristics, sleep disorders, and scores comorbidities on OS and OSA groups in outpatients at the Respiratory Units of Can Tho University of Medicine and Pharmacy Hospital (RU-CTUMP); surveyed respiratory symptom severity, airway obstruction, and aerosol treatment characteristics in OS patients; and determined the correlations between sleep disorder severity and specific patient characteristics.

Methods
A cross-sectional, single-center descriptive study was conducted. We enrolled 48 outpatients at the RU-CTUMP in the study in three months. The patients were divided into two groups with overlapped COPD and OSA (OS, n = 30) vs. OSA-only (n = 18). Patients were asked to complete the demographic questionnaires, Epworth Sleepiness Scale (ESS) scores, STOP-Bang questionnaire, and Snoring Severity Scale (SSS). They were assessed for pulmonary function tests (PFTs) to confirm their COPD diagnosis, overnight respiratory polygraphy (Nox T3x), and Apnea-Hypopnea Index (AHI) to evaluate the severity of OSA, Charlson index to evaluate comorbidities, and their medication history.

Results
In the OS group, 100% of the patients suffered from dyspnea with the mean mMRC scores of 2.83 ± 0.75, mean FEV1 was 60.07 ± 23.09%, and 86% received inhaled medicine. In both groups, all participants suffered from 1 - ≥ 2 comorbidities. Overlapped patients had more comorbidities than OSA-only patients (Charlson scores of 2.33 and 1.17, respectively). There were significant correlations between the AHI value and the body mass index, neck circumferences, STOP-Bang score, the value of the Snoring Severity Scale, and minimum SpO2 (r = 0.45, 0.43, 0.46, 0.44, -0.69, respectively). In addition, COPD was a risk factor for OSA (OR = 1.125).

Conclusion
Home sleep testing in outpatients with COPD in RU-CTUMP revealed an increased prevalence of OSA compared to the OSA-only group. One of the most common comorbidities in individuals with overlap syndrome is hypertension, which is at least as common as in sleep apneic-only patients and may contribute to the disease's overall severity and prognosis.

Support (if any)
0547 Phenotyping of Obstructive Sleep Apnea and its Difference in mortality
Authors: Seo Min Cheol , Shin Jiyoon , Lee Kyung Hwa , Jeon Jeong Eun , Lee Ha Young , Park Cho Won , Kim Sun-Young , Lee Yu Jin 
Published: May 2023

Abstract

Introduction
Obstructive sleep apnea (OSA), which is associated with a high mortality, is a heterogeneous disease that is affected by various pathophysiology. Although the severity of OSA is divided based on apnea-hypopnea index (AHI), AHI alone did not sufficiently represent these pathologies. The objective of this study is to categorize OSA using PSG data and compare the characteristics of each group including mortality.

Methods
7,247 subjects were recruited at the Center for Sleep and Chronobiology, Seoul National University Hospital from June 2004 to December 2021. Demographic data, polysomnography, Sleep scale including Epworth sleepiness scale, Pittsburgh sleep quality index, Beck depression inventory, and Beck anxiety inventory were performed. After categorizing OSA using K-mean cluster analysis, Kaplan-Meir survival analysis and Cox proportional hazard regression analysis were used to evaluate all-cause mortality and hazard ratios.

Results
Three clusters were identified; Cluster 1 was associated with moderate OSA (mean AHI=19.28/h), high sleep efficiency and low arousal, Cluster 2 with moderate OSA (mean AHI=24.81/h), low sleep efficiency and high arousal, Cluster 3 with the most severe OSA (mean AHI=64.76/h), obese, and decreased O2 saturation. Conventional classification of OSA showed no difference in mortality between group, whereas Cluster 1 and Cluster 3 showed significant higher all-cause mortality compared to not-OSA group (Cluster 1, Log rank p=0.008; Cluster 3 Log rank p&lt; 0.001). The risk of mortality was also significantly increased in cluster 1 (HR 2.048, 95% CI 1.265-3.317, p=0.004) and cluster 3 (HR 3.686, 95% CI 1.871-7.262, p&lt; 0.001). These results were also observed after adjustment for sex, age, BMI and comorbid disease (Cluster 1, HR 2.053, 95% CI 1.197-3.518, p=0.009; Cluster 4, HR 2.640, 95% CI 1.230-5.666, p=0.012).

Conclusion
Phenotyping of OSA considered multiple variables is more appropriate to predict mortality than conventional classification based on AHI. In addition to evaluate patient with severe OSA, patients with moderate OSA who shows relatively good sleep and low arousal should be cautiously evaluated and monitored.

Support (if any)
This study was supported by the Technology Innovation Infrastructure program through the Korea Institute for Advancement of Technology funded by the Ministry of Trade, Industry and Energy.(study no.: P0014279, 20009210, Dr. Yu Jin Lee)