Correction: Detection of obstructive sleep apnea using Belun Sleep Platform wearable with neural network-based algorithm and its combined use with STOP-Bang questionnaire.

[This corrects the article DOI: 10.1371/journal.pone.0258040.].

Belun Ring (Belun Sleep System BLS-100): Deep learning-facilitated wearable enables obstructive sleep apnea detection, apnea severity categorization, and sleep stage classification in patients suspected of obstructive sleep apnea.

GOAL AND AIMS: Our objective was to evaluate the performance of Belun Ring with second-generation deep learning algorithms in obstructive sleep apnea (OSA) detection, OSA severity categorization, and sleep stage classification. FOCUS TECHNOLOGY: Belun Ring with second-generation deep learning algorithms REFERENCE TECHNOLOGY: In-lab polysomnography (PSG) SAMPLE: Eighty-four subjects (M: F = 1:1) referred for an overnight sleep study were eligible. Of these, 26% had PSG-AHI<5; 24% had PSG-AHI 5-15; 23% had PSG-AHI 15-30; 27% had PSG-AHI ≥ 30. DESIGN: Rigorous performance evaluation by comparing Belun Ring to concurrent in-lab PSG using the 4% rule. CORE ANALYTICS: Pearson's correlation coefficient, Student's paired t-test, diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, Cohen's kappa coefficient (kappa), Bland-Altman plots with bias and limits of agreement, receiver operating characteristics curves with area under the curve, and confusion matrix. CORE OUTCOMES: The accuracy, sensitivity, specificity, and kappa in categorizing AHI ≥ 5 were 0.85, 0.92, 0.64, and 0.58, respectively. The accuracy, sensitivity, specificity, and Kappa in categorizing AHI ≥ 15 were 0.89, 0.91, 0.88, and 0.79, respectively. The accuracy, sensitivity, specificity, and Kappa in categorizing AHI ≥ 30 were 0.91, 0.83, 0.93, and 0.76, respectively. BSP2 also achieved an accuracy of 0.88 in detecting wake, 0.82 in detecting NREM, and 0.90 in detecting REM sleep. CORE CONCLUSION: Belun Ring with second-generation algorithms detected OSA with good accuracy and demonstrated a moderate-to-substantial agreement in categorizing OSA severity and classifying sleep stages.

The Belun sleep platform to diagnose obstructive sleep apnea in patients with hypertension and high cardiovascular risk.

STUDY OBJECTIVE: Current hypertension guidelines recommend that at-risk individuals be screened for obstructive sleep apnea (OSA). The Belun Ring is a wearable OSA diagnostic device worn on the palmar side of the proximal phalanx of the index finger. METHODS: We recruited 129 participants (age: 60 ±â€Š8 years, male sex: 88%, BMI: 27 ±â€Š4 kg/m 2 ) with hypertension and high cardiovascular risk for a simultaneous polysomnography and Belun Ring monitoring for one night. Epworth Sleepiness Scale score more than 10 was detected in 27 (21.0%) participants. RESULTS: In the 127 participants who completed the study, the apnea-hypopnea index (AHI) derived from polysomnography was 18.1 (interquartile range: 33.0) events/h and that derived from the Belun Ring was 19.5 (interquartile range: 23.3) events/h [intraclass correlation coefficient: 0.882, 95% confidence interval (95% CI): 0.837-0.916]. A Bland-Altman plot showed the difference between the Belun Ring and polysomnography AHIs to be -1.3 ±â€Š10.4 events/h. Area under the receiver operating characteristic for the Belun Ring AHI was 0.961 (95% CI: 0.932-0.990, P  < 0.001). When the Belun Ring AHI of at least 15 events/h was used to diagnose OSA, the sensitivity, specificity, positive predictive value, and negative predictive value were 95.7, 77.6, 85.3, and 93.8%, respectively. The overall accuracy was 87.4%. The Cohen's kappa agreement was 0.74 ±â€Š0.09 ( P  < 0.001). Similar results were obtained when the oxygen desaturation index was used to diagnose OSA. CONCLUSION: A high prevalence of OSA was detected in patients with hypertension and high cardiovascular risk. The Belun Ring is a reliable device for OSA diagnosis similar to polysomnography.

COVID-19 Vaccination Perceptions Among Young Adults of Color in the San Francisco Bay Area.

Background: COVID-19 vaccination rates among U.S. young adults, particularly in communities of color, remain lower than other age groups. We conducted a qualitative, community-based participatory study to explore beliefs and attitudes about COVID-19 vaccines among young adults in Black/African American, Latinx, and Asian American or Pacific Islander (AAPI) communities in the San Francisco Bay Area. Methods: We conducted six focus groups between June and August 2021. Participants were recruited by partnering with community-based organizations in the San Francisco Bay Area. Focus groups included Black/African American (N=13), Latinx (N=20), and AAPI (N=12) participants between 18 and 30 years of age. Emerging themes were identified using a modified Grounded Theory approach. Results: Prominent themes among all three racial-ethnic groups included mistrust in medical and government institutions, strong conviction about self-agency in health decision-making, and exposure to a thicket of contradictory information and misinformation in social media. Social benefit and a sense of familial and societal responsibility were often mentioned as reasons to get vaccinated. Young adult mistrust had a generational flavor fueled by anger about increasing inequity, the profit-orientation of pharmaceutical companies and health institutions, society's failure to rectify injustice, and pessimism about life prospects. Conclusion: Factors influencing vaccine readiness among Black/African American, Latinx, and AAPI young adults have a distinct generational and life-course texture. Outreach efforts should appeal to young adults' interest in family and social responsibility and the social benefits of vaccination, while being cognizant of the friction mandates pose for young adults' sense of self-agency. Efforts will be most effective coming from trusted messengers with a proven commitment to communities of color and health equity.

COVID-19 vaccination readiness among multiple racial and ethnic groups in the San Francisco Bay Area: A qualitative analysis.

BACKGROUND: COVID-19 vaccination rates are lower among historically marginalized populations, including Black/African American and Latinx populations, threatening to contribute to already high COVID-19 morbidity and mortality disparities for these groups. We conducted a community-based participatory research study using qualitative methods to explore knowledge and beliefs about COVID-19 vaccination among Black/African American, Latinx, and Chinese American residents of the San Francisco Bay Area and assess their views on vaccination outreach and delivery strategies. METHODS AND FINDINGS: Data were collected from January 14, 2021, to February 24, 2021, with adult residents (N = 109 [Female: N = 76; 70%]) in San Francisco. Focus groups (N = 10) and in-depth interviews (N = 25) were conducted among Black/African Americans (N = 35), Latinx (N = 40), and Chinese Americans (n = 34) in English, Spanish, Cantonese, or Mandarin. Themes were identified using grounded field theory, and included misinformation, mistrust of government and health institutions, and linguistic and other barriers to vaccine access. All three racial/ethnic groups had experiences with vaccine misinformation and information overload. Many African American and Latinx participants cited structural and interpersonal racism, and anti-immigrant discrimination, as factors reducing their trust in government and public health disseminated information and their willingness to be vaccinated. Participants expressed trust in community-based organizations, including faith-based organizations and community-run clinics. Participants often experienced barriers to vaccine access, such as transportation to drive-in sites, with Latinx and Chinese American groups also frequently citing language barriers. CONCLUSIONS: Vaccine outreach strategies must acknowledge how longstanding systemic, institutional, and structural racism contributes to mistrust in government and health institutions and engage with and support trusted messengers from the community to eliminate cultural, linguistic, and other barriers to vaccine access.

Detection of obstructive sleep apnea using Belun Sleep Platform wearable with neural network-based algorithm and its combined use with STOP-Bang questionnaire.

Many wearables allow physiological data acquisition in sleep and enable clinicians to assess sleep outside of sleep labs. Belun Sleep Platform (BSP) is a novel neural network-based home sleep apnea testing system utilizing a wearable ring device to detect obstructive sleep apnea (OSA). The objective of the study is to assess the performance of BSP for the evaluation of OSA. Subjects who take heart rate-affecting medications and those with non-arrhythmic comorbidities were included in this cohort. Polysomnography (PSG) studies were performed simultaneously with the Belun Ring in individuals who were referred to the sleep lab for an overnight sleep study. The sleep studies were manually scored using the American Academy of Sleep Medicine Scoring Manual (version 2.4) with 4% desaturation hypopnea criteria. A total of 78 subjects were recruited. Of these, 45% had AHI < 5; 18% had AHI 5-15; 19% had AHI 15-30; 18% had AHI ≥ 30. The Belun apnea-hypopnea index (bAHI) correlated well with the PSG-AHI (r = 0.888, P < 0.001). The Belun total sleep time (bTST) and PSG-TST had a high correlation coefficient (r = 0.967, P < 0.001). The accuracy, sensitivity, specificity in categorizing AHI ≥ 15 were 0.808 [95% CI, 0.703-0.888], 0.931 [95% CI, 0.772-0.992], and 0.735 [95% CI, 0.589-0.850], respectively. The use of beta-blocker/calcium-receptor antagonist and the presence of comorbidities did not negatively affect the sensitivity and specificity of BSP in predicting OSA. A diagnostic algorithm combining STOP-Bang cutoff of 5 and bAHI cutoff of 15 events/h demonstrated an accuracy, sensitivity, specificity of 0.938 [95% CI, 0.828-0.987], 0.944 [95% CI, 0.727-0.999], and 0.933 [95% CI, 0.779-0.992], respectively, for the diagnosis of moderate to severe OSA. BSP is a promising testing tool for OSA assessment and can potentially be incorporated into clinical practices for the identification of OSA. Trial registration: ClinicalTrial.org NCT03997916 https://clinicaltrials.gov/ct2/show/NCT03997916?term=belun+ring&draw=2&rank=1.

Belun Ring Platform: a novel home sleep apnea testing system for assessment of obstructive sleep apnea.

STUDY OBJECTIVES: The objective of the study is to validate the performance of Belun Ring Platform, a novel home sleep apnea testing system using a patented pulse oximeter sensor and a proprietary cloud-based neural networks algorithm. METHODS: The Belun Ring captures oxygen saturation, photoplethysmography, and accelerometer signals. The Belun Ring total sleep time is derived from features extracted from accelerometer, oxygen saturation, and photoplethysmography signals. The Belun Ring respiratory event index is derived from Belun Ring total sleep time and features extracted from heart rate variability and oxygen saturation changes. A total of 50 adults without significant cardiopulmonary or neuromuscular comorbidities and heart rate affecting medications were evaluated. In-lab sleep studies were performed simultaneously with the Ring and the studies were manually scored using the American Academy of Sleep Medicine Scoring Manual 4% desaturation criteria. RESULTS: The Belun Ring respiratory event index correlated well with the polysomnography-apnea-hypopnea index (AHI; r = .894, P < .001). The sensitivity and specificity in categorizing AHI ≥ 15 events/h were 0.85 and 0.87, respectively, and the positive predictive value and negative predictive value were 0.88 and 0.83, respectively. The Belun Ring total sleep time also correlated well with the polysomnography-total sleep time (r = .945, P < .001). Although the Belun Ring Platform has a good overall performance, it tends to overestimate AHI in individuals with AHI under 15 events/h and underestimate AHI in those with AHI over 15 events/h. Conclusions: In this proof-of-concept study, the Belun Ring Platform demonstrated a reasonable accuracy in predicting AHI and total sleep time in patients without significant comorbidities and heart rate-affecting medications. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT04121923; Identifier: NCT04121923.

Therapeutic drug monitoring of mexiletine at a large academic medical center.

INTRODUCTION: The therapeutic trough range for mexiletine (0.8-2 mcg/mL) was largely established in the setting of arrhythmia prophylaxis following myocardial infarction. OBJECTIVE: Describe the usage patterns of serum mexiletine concentrations and the impact of these concentrations on mexiletine dosing in modern practice for ventricular arrhythmia treatment. METHODS: A single-center, retrospective analysis was conducted using the electronic medical record to identify serum mexiletine concentrations drawn between December 2004 and December 2014. The primary endpoint was the incidence of mexiletine concentrations drawn as troughs. Secondary outcomes included the incidence of mexiletine concentrations that prompted a dose change, association between adverse events and elevated concentrations, and association between baseline characteristics and mexiletine concentrations. RESULTS: A total of 237 individual concentrations were included for analysis with 109 (46.0%) drawn appropriately as trough concentrations. Only 31 (13.1%) of the 237 concentrations drawn prompted a dose change. Mexiletine was primarily used for the treatment of ventricular arrhythmias (96.2%), and 108 (45.6%) concentrations were drawn in an effort to assess efficacy. The median concentration was statistically different between patients with and without an adverse event (0.8 vs 0.7 mcg/mL, respectively; p = 0.017), but may not represent a clinical significance. Patients with hepatic dysfunction had higher median concentrations compared to those without hepatic dysfunction (1.30 vs 1.07 mcg/mL; p = 0.01). CONCLUSION: Mexiletine concentrations are often drawn at inappropriate times and seldom influence a dose change. This study suggests that routine monitoring of mexiletine concentrations may not be necessary; however, therapeutic drug monitoring may be considered in patients with hepatic dysfunction or to confirm mexiletine absorption in patients where this represents a concern.