Faculty Bibliography

BACKGROUND:Clinical trial transparency is important for scientific research and for the good of the general public. Diversity of study samples by race/ethnicity, gender, and age is important to ensure that results are generalizable. Moreover, reporting results might also be necessary to engage racial/ethnic minorities in clinical research. The primary objective of this study was to describe the results of clinical studies conducted for obstructive sleep apnea (OSA) and insomnia, two of the most prevalent sleep disorders. The secondary objective was to identify which factors were associated with voluntarily reporting the results. METHODS:We reviewed ClinicalTrials.gov, the public database of biomedical and behavioral research operated by the United States (U.S.) National Library of Medicine at the National Institutes of Health to ascertain the reports of demographic variables, including race/ethnicity of the studies conducted for OSA and insomnia. Since reporting race/ethnicity was an optional data feature, we searched for publications in PubMed using the unique national clinical trial identification number (NCTID). The national clinical trial identification number is assigned as soon as the trial is registered. The article extraction was conducted by graduate students and supervised by N.J.W. RESULTS:We identified 427 studies on OSA and 404 studies on insomnia. Results were reported for 122 studies. Based on the 122 studies with results that included studies that were terminated (n = 16) and/or completed (n = 105), and one study was listed as "active" but not recruiting. 46.7% studies involved drugs, 30.3% studied a medical device, and 8.2% investigated behavioral interventions. The age range of subjects was 2-99 years of age and 16.4% included an age range of 35-50 years. Twenty-nine studies (23.8%) reported race/ethnicity in ClinicalTrials.gov. Of these, 74% of subjects were white (n = 2,953); 20% black (n = 822); 1% Asian American (n = 40); 2% Hispanic/Latino (n = 77); and 3% of study subjects identified race/ethnicity as "other" (n = 118). With the PubMed search, we found an additional 24 studies that reported race/ethnicity. There was no difference in reports of race/ethnicity between studies for insomnia and studies for OSA. The intervention type labeled as "behavioral" was a significant predictor (odds ratio: 12.49, p-value=< 0.05, confidence interval: 1.002-155.62) for reporting results. CONCLUSION/CONCLUSIONS:The National Institutes of Health has mandated federally funded research include women and minorities and that they are representative of the U.S. POPULATION/METHODS:Though gender was reported, few investigators and study sponsors reported the results of race/ethnicity, which begs the question about trial transparency for the future of sleep research. Presumably, the lack of reporting is related to low enrollment of ethnic/minorities included in these studies. Nonetheless, our key finding warrants increased attention to minority participation in sleep clinical studies and trial transparency.

PURPOSE OF REVIEW/OBJECTIVE:In this current review, we describe the benefits of community-based and "precision and personalized population health" (P3H) approaches to assessing and addressing sleep health problems and sleep-related cardiovascular diseases (CVD) among vulnerable populations such as racial/ethnic minorities, the elderly, and the socioeconomically disadvantaged. RECENT FINDINGS/RESULTS:Very few sleep health programs utilize a community-based or P3H approach, which may account for low estimates of sleep health problems, related CVD outcomes, and inadequate healthcare infrastructure to address sleep-related health outcomes at the community and population level. We describe community-based and P3H approaches and programs as solutions to accurately capture estimates of sleep health and reduce burden of sleep health problems and corollary CVD outcomes at the level of the community and population. Specifically, we describe seven critical steps needed to successfully implement a community-based and P3H approach to address sleep health problems. Community-based and P3H approaches are effective strategies to assessing and addressing sleep health problems and related health conditions.

BACKGROUND:Participation in clinical trials among people of color remains low, compared with white subjects. This protocol describes the development of "Advancing People of Color in Clinical Trials Now!" (ACT Now!), a culturally tailored website designed to influence clinical trial decision making among people of color. OBJECTIVE:This cluster randomized study aims to test the efficacy of a culturally tailored website to increase literacy, self-efficacy, and willingness to enroll in clinical trials among people of color. METHODS:ACT Now! is a randomized trial including 2 groups: (1) intervention group (n=50) with access to the culturally tailored website and (2) control group (n=50) exposed to a standard clinical recruitment website. Clinical trial literacy and willingness to enroll in a clinical trial will be measured before and after exposure to the website corresponding to their assigned group (intervention or control). Surveys will be conducted at baseline and during the 1-month postintervention and 3-month follow-up. Website architecture and wireframing will be informed by the literature and experts in the field. Statistical analysis will be conducted using a two-tailed t test, with 80% power, at .05 alpha level, to increase clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials 3 months post intervention. RESULTS:We will design a culturally tailored website that will provide leverage for community stakeholders to influence clinical trial literacy, self-efficacy, and willingness to enroll in clinical trials among racial and ethnic groups. ACT Now! applies a community-based participatory research approach through the use of a community steering committee (CSC). The CSC provides input during the research study conception, development, implementation, and enrollment. CSC relationships help foster trust among communities of color. ACT Now! has the potential to fill a gap in clinical trial enrollment among people of color through an accessible web-based website. This study was funded in July 2017 and obtained institutional review board approval in spring 2017. As of December 2019, we had enrolled 100 participants. Data analyses are expected to be completed by June 2020, and expected results are to be published in fall 2020. CONCLUSIONS:ACT Now! has the potential to fill an important gap in clinical trial enrollment among people of color through an accessible web-based website. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT03243071; https://clinicaltrials.gov/ct2/show/NCT00102401. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)/UNASSIGNED:DERR1-10.2196/17589.

BACKGROUND:This study examined the relationships between resilience and sleep disturbance in a diverse sample of older women with a history of hypertension and whether this relationship is moderated by individuals' race/ethnicity. METHODS:Sample includes 700 females from a community-based study in Brooklyn, New York with a mean age of 60.7 years (SD=6.52). Of the participants, 28.1% were born in the U.S.; 71% were African-descent, 17.4% were European and 11.6% were Hispanics descents. Data were gathered on demographics and sleep disturbance using the Comprehensive Assessment and Referral Evaluation (CARE) and the Stress Index Scale (SIS). Resilience Factors were assessed with both the Index of Self-Regulation of Emotion (ISE) and religious health beliefs. Chi-Square, Anova, Student t-tests, and multilinear regression analysis were conducted to explore associations between resilience factors and sleep disturbance. Associations between resilience factors and sleep disturbance were examined using stratified multilinear regression analysis in three models by race/ethnicity. Regression models was conducted examining the interaction between resilience factors and stress RESULTS: Resilience factor, ISE emerged as the strongest independent predictor of sleep disturbance [B(SE) = -0.368(0.008); p < .001] for African descents. ISE was not a significant predictor of sleep disturbance among Hispanic participants [B(SE) = -0.218(0.022);p = .052], however interaction effect analysis revealed that stress level moderates significantly the relationship between ISE, and their sleep disturbance [B(SE) = 0.243(0.001);p = .036]. CONCLUSIONS:Results of our study suggest that resilience factors might be a more important protective factor for sleep disturbance among diverse older females.

INTRODUCTION/BACKGROUND:The influence of aging on the clinical presentation of obstructive sleep apnea (OSA) is not well characterized in US veterans. Our aims were to (1) examine age and established predictors of sleepiness and insomnia symptoms in veterans with OSA and (2) determine if the relationship between predictors of the Epworth sleepiness scale (ESS) and insomnia severity index (ISI) depended on age. METHODS:We performed a retrospective analysis of veterans diagnosed with OSA at the Miami VA in 2014. On polysomnography (PSG) night, questionnaires were completed querying socio-demographics, insomnia (ISI), sleepiness (ESS), and self-reported sleep duration. Regression modeling was performed to explore association of variables with (1) ESS and (2) ISI. Analyses were performed in two steps: (1) variables were tested for main effects and (2) product of age and each variable found to have an association at a significance level of p < 0.10 with primary outcome were entered separately to test for interaction. RESULTS:The sample consisted of 483 veterans (93% male, age 52 ± 13 years, 41% black, 34% Hispanic). Having a regular bed partner, higher weighted medical comorbidities, chronic pain diagnosis, and shorter sleep duration were associated with ESS. Age did not moderate the relationship between these variables and ESS. Younger age, Hispanic ethnicity, higher educational level, shorter sleep duration, mood, and pain diagnoses were each associated with the ISI. Furthermore, an age-sleep duration interaction term was associated with the ISI (b = - 0.03; p = 0.005). For all participants, there was an inverse relationship between sleep duration and ISI. However, for any sleep duration, older veterans reported lower levels of insomnia than younger veterans. DISCUSSION/CONCLUSIONS:Older veterans with OSA may report lower ISI scores. Alternative assessment methods for comorbid insomnia among older individuals with OSA may be needed.

Objective/UNASSIGNED:To elucidate women's experiences with opioid medications and their perspectives on provider education regarding opioid use, risks and safety. Methods/UNASSIGNED:Women with a self-reported history of pain who had been prescribed opioids were recruited in 2016 using a convenience sampling approach that included an online social media campaign. Participants (N=154) completed online surveys and open-ended questions regarding their experiences with pain and opioids, and their perspectives on the quality of education they received from their providers. Results/UNASSIGNED:Participants reported receiving insufficient education about opioid-related side effects, as reflected in both ratings for the quantity and quality of education they received from their providers. Non-white participants reported lower quantity and poorer quality of provider education (p<0.05). Themes identified from the qualitative data included frustrations with pain management options, fear of opioids, stigma associated with opioid use, and the need for improved provider education and patient-provider communication. Conclusion/UNASSIGNED:Findings suggest that from a patient's perspective, there is a need for enhanced patient-provider communication and education regarding pain management and potential opioid-related side effects. Improved physician communication and education could promote shared decision-making and result in enhanced satisfaction with care and health outcomes.

Introduction/UNASSIGNED:Mentorship is crucial for academic success. And yet, there are few mentoring programs that address the needs of underrepresented, racially/ethnically diverse junior faculty conducting health-related research in the United States. Methods/UNASSIGNED:To expand mentoring capacity for these racially/ethnically diverse faculty, we developed a Peer Mentor Development Program (PMDP) to prepare near-peers, who have similar characteristics and personal experiences, to provide support to participants in an NIH-PRIDE funded Institute. The PMDP program is designed based on the 8-year experience of the Mentor Development Program of the NYU-Health and Hospitals Clinical Translational Science Institute. Annually, up to six alumni are selected into the PMDP, participate in the 12-hour program over 4 days, are paired with 1 to 3 scholar participants to mentor and join monthly PMDP conference calls during the ensuing year. Results/UNASSIGNED:We describe the program, participant experience and lessons learned from our first 18 peer mentors in three PMDP cohorts. Additionally, all 18 peer mentors completed a post-evaluation survey to assess the program. Overall, peers agreed that participating in the PMDP enhanced most of the specific skills targeted. Participants rated 53%-86% of skills as "more than before" participating in PMDP, demonstrating the appreciation and impact of the program. Conclusions/UNASSIGNED:The PMDP may be a model for higher education and academic medicine programs committed to mentoring and retaining racially/ethnically diverse faculty and ultimately contributing to reducing entrenched health disparities between majority and minority populations.

OBJECTIVES/OBJECTIVE:Determine the current rate of patient-provider sleep discussions and identify factors associated with occurrence of these discussions. DESIGN/METHODS:Secondary cross-sectional analysis of self-report data collected during the Sleep and Healthy Activity Diet Environment and Socialization study. Logistic regressions were used. SETTING/METHODS:Urban and suburban Southeastern Pennsylvania PARTICIPANTS: A total of n = 998 adults (aged 22-60), 38.6% female, racially and socioeconomically diverse, from urban and suburban Southeastern Pennsylvania. MEASUREMENTS/METHODS:Outcome measures were responses to 3 questions: (1) ever discussed sleep with a provider, (2) a provider ever discussed importance of sleep schedule, and (3) a provider ever discussed importance of enough sleep. Descriptive/independent variables included demographic factors and a wide range of patient-reported measures of health and sleep habits. RESULTS:About a third of individuals have ever discussed sleep with a provider. Factors associated with higher odds of sleep-related discussions included sleep medication use, worse insomnia severity, race (Black/African American, Hispanic, Latino, other/multiracial), female sex, higher education, higher body mass index, and worse depression severity. Factors associated with lower odds were Asian race and low income. Sleep discussions were not associated with certain factors indicative of sleep disorders: sleep duration, snoring, shift work schedule, not working, and anxiety. CONCLUSIONS:Low rates of patient-provider sleep discussions and factors associated (or not) with their occurrence indicate missed opportunities for improved health outcomes.

Blacks are at greater risk for lower sleep quality and higher risk for obstructive sleep apnea (OSA) than other racial groups. In this study, we summarize the development of a tailored website including visuals, key messages, and video narratives, to promote awareness about sleep apnea among community-dwelling blacks. We utilized mixed methods, including in-depth interviews, usability-testing procedures, and brief surveys (n = 9, 55% female, 100% black, average age 38.5 years). Themes from the qualitative analysis illuminated varied knowledge regarding OSA symptoms and prevalent self-reported experience with sleep disturbance and OSA symptoms (e.g., snoring). On a scale from 1 (not at all) to 5 (very high), participants provided favorable ratings of website usefulness (mean = 4.9), user friendliness (mean = 4.9) and attractiveness (mean = 4.3). Our findings suggest although tailored health communication has potential for serving as a tool for advancing health equity, usability-testing of health materials is critical to ensure that culturally and linguistically tailored messages are acceptable and actionable in the intended population.

Introduction: The influence of aging on the symptomatic presentation of obstructive sleep apnea (OSA) is not well-characterized in US veterans. Our aims were to 1) examine age and established predictors of sleepiness and insomnia symptoms in US veterans with OSA and 2) determine if the relationship between predictors and sleepiness and insomnia depended on age.
Method(s): We performed a retrospective analysis of US veterans newly-diagnosed with OSA at the Miami VA in 2015. On diagnostic PSG night (76% attended studies), questionnaires were completed querying demographics, social characteristics, insomnia symptoms (Insomnia severity index [ISI]), sleepiness (Epworth sleepiness scale [ESS]) and self-reported sleep duration. Medical and psychiatric comorbidities were assessed with electronic medical record review. Linear regression modeling was used to explore the association of variables with 1) ESS and 2) ISI. Regression analyses were performed in two steps: 1) all variables were entered simultaneously testing for main effects, 2) the product of age and each variable found to have an association at a significance level of p < 0.10 with the primary outcome was entered separately to test for interaction.
Result(s): The sample consisted of 483 veterans (93% male, age 52 +/- 13 yrs, 41% black, 34% Hispanic) diagnosed with OSA (AHI 36 +/- 28 events/hr of sleep). Having a regular bed partner, higher weighted medical comorbidities, chronic pain diagnosis, and shorter sleep duration were associated with ESS. Age did not moderate the relationship between these variables and the ESS. Younger age, Hispanic ethnicity, higher educational level, shorter sleep duration, mood and pain diagnoses were each associated with the ISI. Furthermore, an age-sleep duration interaction term was associated with the ISI (b = -0.03; p=0.005). For all participants, there was an inverse relationship between sleep duration and ISI scores. However, for any sleep duration, older veterans reported a lower level of insomnia symptoms than younger veterans.
Conclusion(s): Older veterans with OSA may report less sleep complaints. Personalized screening methods for older individuals with OSA may be needed