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Reporting results in U.S. clinical trials for obstructive sleep apnea and insomnia: How transparent are they?
He, Zhe; Wallace, Douglas M; Barnes, Andrea; Tang, Xiang; Jean-Louis, Girardin; Williams, Natasha J
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.
PMID: 32179065
ISSN: 2352-7226
CID: 4352522
Do symptoms of sleepiness and insomnia in US veterans with obstructive sleep apnea vary by age?
Agudelo, C; Ramos, A R; Williams, N J; Wallace, D M
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.
PMCID:6824916
PMID: 31044372
ISSN: 1522-1709
CID: 4343932
Women's Perspectives On Provider Education Regarding Opioid Use
Kalinowski, Jolaade; Wallace, Barbara C; Williams, Natasha J; Spruill, Tanya M
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.
PMCID:6957101
PMID: 32021393
ISSN: 1178-7090
CID: 4300262
Race as a Social Determinant of Sleep Health
Chapter by: Robins, Rebecca; Seixas, Azizi; Williams, Natasha; Kim, Byoungjun; Blanc, Judite; Nunes, Joao; Jean-Louis, Girardin
in: The social epidemiology of sleep by Duncan, Dustin T; Kawachi, Ichiro; Redline, Susan [Eds]
New York, NY : Oxford University Press, [2019]
pp. ?-
ISBN: 9780190930448
CID: 5403952
Are sleep patterns influenced by race/ethnicity - a marker of relative advantage or disadvantage? Evidence to date
Johnson, Dayna A; Jackson, Chandra L; Williams, Natasha J; Alcántara, Carmela
Sleep is a fundamental necessity of life. However, sleep health and sleep disorders are not equitably distributed across racial/ethnic groups. In fact, growing research consistently demonstrates that racial/ethnic minorities are more likely to experience, for instance, shorter sleep durations, less deep sleep, inconsistent sleep timing, and lower sleep continuity in comparison to Whites. However, racial/ethnic disparities in reports of sleepiness and sleep complaints are inconsistent. Racial/ethnic groups have significant heterogeneity, yet within-group analyses are limited. Among the few published within-group analyses, there are differences in sleep between non-US-born and US-born racial/ethnic groups, but the group with the more favorable sleep profile is consistent for non-US-born Latinos compared to US-born Latinos and Whites but unclear for other racial/ethnic minority groups. These sleep health disparities are a significant public health problem that should garner support for more observational, experimental, intervention, and policy/implementation research. In this review, we 1) summarize current evidence related to racial/ethnic disparities in sleep health and within-group differences, focusing on the sleep of the following racial/ethnic minority categories that are defined by the United States Office of Management and Budget as: American Indian/Alaska Native, Asian, African American/Black, Hispanic/Latino, and Native Hawaiian/Pacific Islander; 2) discuss measurement challenges related to investigating sleep health disparities; 3) discuss potential contributors to sleep health disparities; 4) present promising interventions to address sleep health disparities; and 5) discuss future research directions on intersectionality and sleep health.
PMCID:6664254
PMID: 31440109
ISSN: 1179-1608
CID: 4047042
Doctor-patient sleep discussions for US adults: results from the SHADES study
Klingman, Karen J; Williams, Natasha J; Perlis, Michael L; Grandner, Michael A
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.
PMID: 31422068
ISSN: 2352-7226
CID: 4046522
Sleep disparities in the United States and the impact of poverty [Meeting Abstract]
Begay, T; Gooneratne, N; Williams, N; Seixas, A; Jean-Louis, G; Gilles, A; Killgore, W D S; Alfonso-Miller, P; Grandner, M A
Introduction: Previous studies have shown that racial/ethnic minorities are more likely to be short and/or long sleepers, which may increase risk for morbidity/mortality. This analysis provides a more recent update from a very large national dataset, including representation of additional groups and examination of the role of poverty.
Method(s): Data from the 2016 Behavioral Risk Factor Surveillance System (BRFSS, collected by the CDC) were used. N=464,671 adults >18yrs from all US states/territories provided data on sleep, demographics, and socioeconomics. Sleep duration was categorized as very short (<=4h), short (5-6h), normal (7-8h as reference), and long (>=9h). Race/ethnicity was self-reported as Non-Hispanic White, Black/ African-American, Hispanic/Latino, American-Indian/Alaskan-Native (AIAN), Native Hawaiian/Pacific-Islander (NHPI), or Multiracial/Other. Covariates included age, sex, relationship status, education, employment, and home ownership. Interactions were explored with poverty (income<$20,000) were explored. Multinomial logistic regressions were weighted using BRFSS-specific weights.
Result(s): A significant race-by-poverty interaction was seen (p<0.0005). Compared to non-poor Non-Hispanic White, increased very short sleep was seen among those who were non-poor Black/African-American (RRR=2.1, p<0.0005), Asian (RRR=1.6, p=0.001), AIAN (RRR=1.4, p=0.001), NHPI (RRR=2.0, p=0.002), and Multiracial/Other (RRR=2.2, p<0.0005), and poor Non-Hispanic White (RRR=1.8, p<0.0005), Black/African-American (RRR=1.8, p<0.0005), AIAN (RRR=1.5, p=0.007), NHPI (RRR=2.4, p=0.005), and Multiracial/Other (RRR=3.4, p<0.0005). Compared to non-poor White, increased short sleep was seen among non-poor Black/African-American (RRR=1.7, p<0.0005), Asian (RRR=1.3, p<0.0005), AIAN (RRR=1.2, p=0.02), NHPI (RRR=1.3, p=0.02), Multiracial/Other (RRR=1.3, p<0.0005), and poor Non-Hispanic White (RRR=1.3, p<0.0005), Black/African-American (RRR=1.4, p<0.0005), Asian (RRR=1.3, p=0.04), and Multiracial/Other (RRR=2.2, p<0.0005). Compared to non-poor Non-Hispanic White, increased long sleep was seen for Non-Poor Black/African-American (RRR=1.4, p<0.0005), Poor Non-Hispanic White (RRR=1.3, p<0.0005), Black/African-American (RRR=1.4, p<0.0005), and AIAN (RRR=1.3, p<0.05).
Conclusion(s): Established racial/ethnic sleep disparities are supported in this large national sample, with additional information on understudied vulnerable groups including AI/AN and NH/PI. Further, the this study as the contribution of poverty status
EMBASE:627914089
ISSN: 1550-9109
CID: 3926002
Insomnia symptoms and adherence to CPAP: Exploring the role of resilience [Meeting Abstract]
Williams, N J; Butler, M; Roseus, J; Parra, Y; Krieger, A C; Ebben, M; Barnes, A; Wallace, D M; Blanc, J; Chung, A; Jean-Louis, G
Introduction: Several studies have demonstrated that insomnia symptoms negatively impact adherence to Continuous Positive Airway Pressure (CPAP). Yet, little is known about psychosocial factors that may buffer the associated negative effects. The present study explored the role of resilience, the ability to function in the face of or following adversity, on reducing the negative effects of insomnia on CPAP adherence.
Method(s): The study sample included volunteers from a large sleep center enrolling individuals newly diagnosed with Obstructive Sleep Apnea (OSA). For this analysis, we examined volunteers with complete data (n=45) on insomnia severity (based on the Insomnia Severity Index (ISI)), resilience (based on the Connor Davidson Resiliency Scale (CD-RISC)), and objective median hours of CPAP use over the first 30 days of treatment.
Result(s): The mean age was 55.4 years (SD=15.7); 62.2% male, and 33% black. The mean ISI score was 13.0 (SD=6.3), mean CD-RISC was 30.7 (SD=5.7) and mean CPA use over the first 30 days was 5.9 (SD=1.9). In the linear regression, ISI was positively correlated with increased hours of CPAP use (r=-0.305, p=.047). Resilience was not significantly correlated with CPAP use (r=0.216, p=.163), likely attributable to the sample size. ISI correlated with CPAP use among those with low resilience (r=-0.461, p=.027), but not among those with high resilience (r=-0.039, p=.870). There was a significant interaction (B(SE)=0.22 (0.08); p=.005) between ISI and resilience on median hours of CPAP use, indicating that resilience may moderate the association between ISI and hours of CPAP use.
Conclusion(s): Results of our study indicated that resilience is an important factor and may reduce the negative effects of insomnia on CPAP adherence. Notably, the high resilience score in this sample could signal an important target for tailoring CPAP adherence interventions to address unique characteristics of each subgroup
EMBASE:627914497
ISSN: 1550-9109
CID: 3924052
What makes people want to make changes to their sleep? assessment of perceived risks of insufficient sleep as a predictor of intent to improve sleep [Meeting Abstract]
Khader, W; Fernandez, F; Seixas, A; Knowlden, A; Ellis, J; Williams, N; Hale, L; Perlis, M; Jean-Louis, G; Killgore, W D S; Alfonso-Miller, P; Grandner, M A
Introduction: Sleep health is associated with many domains of functioning. Yet, changing behaviors linked to improved sleep health is difficult. Beliefs about the health impact of sleep may motivate behavior change. This analysis examined which beliefs about sleep might motivate sleep behavior change.
Method(s): Data were from the Sleep and Healthy Activity, Diet, Environment, and Socialization (SHADES) study, consisting of N=1007 community-dwelling adults age 22-60. Participants were asked, regarding "the single most important thing you personally could do to improve your sleep," whether participants were in the stage of precontemplation (not considered change), contemplation (considered but not decided), preparation (decided but not acting), and action stages of change from the transtheoretical model. They were also asked items from the Sleep Practices and Attitudes Questionnaire (SPAQ) regarding the degree to which they agree with whether "not getting enough sleep" can cause sleepiness, drowsy driving, weight gain, heart disease, high cholesterol, hypertension, moodiness, lower energy, decreased sex drive, missed days at work, decreased performance, memory/concentration problems, diabetes, and/or tiredness. Ordinal logistic regressions evaluated increased likelihood of stage of change, based on degree of agreement with those statements, adjusted for age, sex, race/ethnicity, and education. Post-hoc analyses also examined sleep duration as an additional covariate.
Result(s): In adjusted analyses, stage of change was associated with degree of agreement that insufficient sleep can cause sleepiness (OR=1.17, p=0.035), weight gain (OR=1.20, p<0.0005), heart disease (OR=1.21, p=0.001), cholesterol (OR=1.13, p=0.047), hypertension (OR=1.16, p=0.014), moodiness (OR=1.42, p<0.0005), decreased energy (OR=1.30, p=0.002), absenteeism (OR=1.13, p=0.007), decreased performance (OR=1.20, p=0.003), concentration/ memory problems (OR=1.23, p=0.004), diabetes (OR=1.14, p=0.042), and feeling tired (OR=1.39, p<0.0005). When sleep duration was added to the model, significant relationships remained for weight, heart, hypertension, moodiness, energy, absenteeism, performance, memory, diabetes, and tiredness.
Conclusion(s): Degree of belief that insufficient sleep can cause outcomes such as moodiness, occupational problems, and health problems may impact whether an individual is contemplating/ attempting to improve their sleep. This may guide education/outreach efforts
EMBASE:627914814
ISSN: 1550-9109
CID: 3926042
Does insomnia symptom severity vary by race/ ethnicity? [Meeting Abstract]
Williams, N J; Boyle, J T; Butler, M; Klingman, K; Jean-Louis, G; Grandner, M A; Perlis, M L
Introduction: While there is epidemiologic evidence that racial/ ethnic minorities report shorter sleep duration and poorer sleep quality than whites, few studies have assessed sleep continuity (SC), variable by variable (e.g., SL, NWAK, WASO, EMA, & TST). The present analysis assesses in a quantitative way whether insomnia symptom severity varies by race/ethnicity.
Method(s): An archival analysis was conducted on an existing database of 4,206 individuals who completed a screening survey on-line at https://urldefense.proofpoint.com/v2/url?u=http- 3A__www.sleeplessinphilly.com&d=DwIBAg&c=j5oPpO0eBH1iio48DtsedeElZfc04rx3ExJHeIIZuCs&r=CY_ mkeBghQnUPnp2mckgsNSbUXISJaiBQUhM-Uz9W58&m=_icVcFoc7ulJmPF3ojT4VQ- keh3a2N4OhtHGRLx7AN4&s=GRc5DD1Hlq9WkqeVHjBH7X9hXNa8mcKsHyVAl9iK8QI&e=. Variables collected included estimates for: sleep latency (SL), number of awakenings (NWAK), wake after sleep onset (WASO), early morning awakenings (EMA) and total sleep time (TST).
Result(s): The sample for the present analysis was comprised of 2,049 whites (63.4%), 1,007 blacks (31.2%), and 175 Hispanics (5.4%). The overall mean age was 39.0+/-14.7, 60.4% of the sample was female, and the average BMI was 28.0+/-7.1. For all SC variables, blacks significantly differed from whites: SL (49.2+/-38.3 vs. 42.8+/-30.5; p<.001); NWAK (2.64+/-1.7 vs. 2.50+/-1.6; p<.001); WASO (47.3+/-43.4 vs. 29.9+/-30.5; p<.000); EMA (63.4+/-41.8 vs. 57.2+/-33.0; p<.000); Hispanics did not significantly differ from whites with respect to the above measures. For self-reported TST, blacks and Hispanics significantly differed from whites (316.4+/-85.1; 356.2+/-73.7; 365.8+/-80.6, respectively; p<0.000).
Conclusion(s): Our results suggest that blacks exhibit marginally worse sleep continuity (statistically significant owing to the large sample sizes) and shorter TSTs. Analysis is ongoing to evaluate Time in Bed [TIB], calculated TST, SE%, sleep period, sleep schedule differences, and percentage of group with Insufficient Sleep Disorder by race, in matched samples
EMBASE:627915051
ISSN: 1550-9109
CID: 3924002