Treatment Trials

17 Clinical Trials for Various Conditions

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COMPLETED
Qualitative Study of Black-White Sleep Disparities
Description

Background: Sleep that does not last long and is low-quality is tied to a range of serious health issues. These range from obesity to early death. Research has shown that black people who are professionals or managers are more likely to have this kind of sleep than their white counterparts. Black people are also at higher risk than whites for health problems caused by insufficient sleep. Researchers want to learn more about why these differences exist. Objective: To study reasons for racial differences in the work-sleep relationship. Eligibility: Adults at least 25 years old who: * Are non-Hispanic black or non-Hispanic white * Are employed and work 38 or more hours a week * Live around Raleigh-Durham-Chapel Hill, NC, or Washington, DC Design: Participants will be screened with questions. They will give sociodemographic data like job title, annual income level, and gender. They will give their contact information. Participants will have 1 study visit. They will be in a closed, private conference room. They will join a focus group. The focus groups will be organized by to race, gender, and occupational class. Participants will give informed consent before the focus group begins. During the focus group, participants will be asked about their perceptions of health in general, and their typical work day. They will be asked about sleep. Participants will also fill out a short questionnaire about their job and sleep habits. Focus groups will be audio recorded. The entire session will last 90 to 120 minutes.

Conditions
COMPLETED
Reducing Sleep Disparities in Minority Children
Description

Inadequate sleep is a major health problem of childhood that often fails to receive attention until significant neurobehavioral and other health problems are noted. Although adequate sleep is essential for normal growth and brain development, studies show that children from minority and economically disadvantaged families are more likely to experience shorter sleep times and more sleep fragmentation compared to their Caucasian and economically advantaged counterparts. As a result, they are disproportionately affected by the adverse health and quality of life consequences of poor sleep. There are currently no intervention studies to the investigators knowledge aimed at addressing sleep disparities by improving sleep duration and sleep hygiene in early school-aged children from minority populations. This study seeks to close the 'sleep gap' that exists between the sleep duration of minority school-aged children and that of their non-minority peers. An interdisciplinary team of researchers and clinicians from Columbia University's Pediatric Lung and Sleep Disorders Center, School of Public Health, Psychiatry Department, and two outpatient clinic systems affiliated with Columbia are collaborating to reduce sleep disparities by improving sleep duration in a group of 5-6 year old minority children. The primary goal of this study is to evaluate the efficacy of a tailored, interactive, educational and behavioral intervention that utilizes trained sleep counselors to assist parents in improving their children's sleep hygiene and reducing risk factors for poor sleep, thereby increasing sleep duration over a 12-month period in a randomized controlled trial of children identified with sleep problems (Aim 1). The investigators will screen 375 parents of 5-6 year old children from 5 primary care clinics to identify children with and without sleep problems and enroll 90 of the 375 children screened who have sleep problems in a randomized controlled trial of an in-home sleep intervention. Using an initial home assessment, baseline actigraphy data, sleep logs recorded by parents, and information regarding risk factors for poor sleep collected from each family during screening, the investigators will work with intervention parents to develop a personalized sleep plan for their children. The investigators will evaluate the effect of the intervention on: a) nightly sleep duration; b) neurocognitive function; and c) behavioral disorders.

Conditions
RECRUITING
Better Lifestyle Counseling for African American Women During Pregnancy
Description

The purpose of this randomized controlled trial is to establish the effectiveness of a culturally targeted and individually tailored behavioral intervention to promote maternal glucose metabolism in African American women.

COMPLETED
Exploring Racial Disparities in Sleep Health and Neurocognitive Function
Description

Despite longer life expectancies due to combination antiretroviral therapy (cART), the prevalence of HIV-associated neurocognitive disorders (HAND) persists thus affecting 52% of the HIV population. Poor sleep quality is commonly reported in older adults and has been related to neurocognitive impairments. This is concerning given studies have shown that up to 75% of adults with HIV experience poor sleep, and by 2020, 70% of adults with HIV will be age 50 and older. It is important to examine sleep quality as it relates to neurocognitive function and HAND in older adults with HIV given its negative impact on cART adherence. Compared to Whites with HIV, African Americans (AA) are disproportionately affected by HIV and are more likely to experience poor sleep quality. This primary goal of this 1-year cross-sectional study is to examine racial differences in sleep quality and neurocognitive function among 60 African Americans and Whites with HIV (age 50+).

Conditions
ACTIVE_NOT_RECRUITING
Predicting Sleep, Smoking, and Lung Health Disparities in African American Adults
Description

This 5-year prospective, observational study will: (1) determine the individual, social, and environmental predictors of sleep duration, quality, latency, efficiency, timing and regularity in African American smokers, (2) quantify the prospective relationship between multiple metrics of sleep with tobacco use, such that a sleep phenotype of risk for smoking is defined, and (3) examine the extent to which short sleep (\<7 hrs) and other unhealthy sleep metrics, predicts lung function through smoking behaviors and inflammation, in 480 African Americans at risk for advancing COPD (GOLD Stage 0-2 and current smoker). Study subjects will be recruited via Temple Health System sites. Following eligibility screening, initially eligible subjects will provide written study consent and complete an in-home sleep assessment to rule out the exclusionary moderate-severe sleep apnea and other sleep disorders. Consenting and eligible subjects will be entered into the study and across the 60-month data collection period, complete 8 assessments: 4 annual clinical based assessments, interspersed by 4 mid-year, phone-based, self-report assessments.

COMPLETED
Addressing Health Disparities in African Americans - Exploring Sleep and Developing Interventions - 2
Description

The purpose of the HD-SLEEP2 study is to help researchers understand sleep in African Americans. The investigators also want to know what factors may affect sleep.

Conditions
COMPLETED
Addressing Health Disparities in African Americans - Exploring Sleep and Developing Interventions
Description

The purpose of the HD-SLEEP1 study is to help researchers understand what African Americans know and think about sleep. The investigators also want to know how to encourage people to participate in research studies designed to improve sleep.

Conditions
RECRUITING
UrbanHEAT: Health Behaviors, Outcomes, and Disparities in Individually Experienced Temperature Across an Urban Community
Description

We are conducting a research study to learn about how individuals living in Washington, DC perceive and experience temperature. Participation in this study will include: 2 remote visits over the phone and/or computer (these will each last about1.5 to 2 hours) * During the remote visits, you will be asked to respond to a series of surveys, so that we can learn about your life, behaviors, and health 2 weeks of data collection where you will be asked to: * Wear monitoring devices * These will collect information on your location and physical activity * We will ask you to wear the monitors on a belt around your waist all day every day during these 2 weeks of data collection. * All of the monitors will be sent to you in the mail. * Leave a temperature tracker near where you sleep to measure the temperature of your environment. * Use a phone app * We will also send you questions through the phone app that will ask about your stress level, sleep duration, sleep quality, and how you feel about the current temperature. Risks of participating in this study are minimal. They include the inconvenience of wearing the monitors and the possibility of a breach of your confidentiality. We are collecting personal information about you and the location monitor will collect information about where you spend your time. We will take every precaution in order to safeguard the data that you provide, including limiting who has access to it, storing it safely, and removing the capacity to identify you individually, as much as possible. You will receive no immediate benefits from participating in this study. We hope what we learn will help us to develop policies and programs to help keep urban populations safe during increasingly warm summer temperatures. You are eligible for this study if you are 18 years of age or older, live in Washington, DC, can read and write in English, and have access to a smartphone that you can use for the 2 week data collection period....

Conditions
NOT_YET_RECRUITING
Adult Sleep Health in the Rural Appalachia and Mississippi Delta Region and Its Relationships With Cardiometabolic Health Disparities.
Description

Rural communities in the southern U.S. suffer a disproportionate burden of morbidity and mortality from cardiometabolic disease, with traditional risk factors explaining only a modest proportion of the excess burden of disease. There is considerable evidence that multiple dimensions of sleep health, including sleep duration, efficiency, timing, and regularity, as well as the disorders sleep apnea and insomnia, affect cardiometabolic disease risk. However, there is currently a lack of systematically developed sleep data in rural populations. The RURAL Sleep Study is an ancillary study to a recently initiated longitudinal epidemiology study in rural Appalachia and Mississippi Delta (the RURAL Study). The RURAL Sleep Study will add measures of sleep health to the complex individual, social and environmental factors and health outcome measures being evaluated by the RURAL Study, by incorporating minimally burdensome measures of multiple dimensions of sleep health. The results are expected to inform health care providers, public health officials, and the general public of the prevalence, risk factors, and consequences of impaired sleep health in these rural communities, providing a critical basis for prevention, recognition, and management of sleep disorders and improvement of sleep and cardiometabolic health.

COMPLETED
Mental Health Disparities in Spanish Speaking Latina Breast Cancer Patients
Description

The purpose of the study is to:Translate a mindfulness program into Spanish for Latina patients with breast cancer.Train a community health worker to facilitate the mindfulness program. Determine if this program is culturally acceptable and feasible, and Obtain pilot data on the program's effectiveness in reducing anxiety and depression

RECRUITING
Reaching for Equity in Sleep Apnea Treatment (REST) Study
Description

This study will test a brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of obstructive sleep apnea.

Conditions
RECRUITING
Obstructive Sleep Apnea Among Somali-Americans
Description

The investigators seek to advance the understanding of obstructive sleep apnea as it relates to different ethnic origins as well as sex differences. The investigators will compare Somali patients with known obstructive sleep apnea (OSA) to individuals without OSA, and to individuals of other ethnic/racial origins to determine the risk factors (genetic and/or physiologic) associated with developing cardiovascular diseases. This will help the investigators to understand the unique sleep pathology of individuals of African descent.

COMPLETED
Reducing Health Disparities for Black Women in the Treatment of Insomnia
Description

Black women are at a higher risk of developing insomnia than other women and insomnia has profound adverse physical and psychological health consequences. There is an internet-delivered treatment program for insomnia that has been shown to be effective in White individuals but there is little evidence of the effectiveness of this treatment among Black women. The goal of this study is to conduct a comparative effectiveness trial of three online insomnia therapies after a 6 month follow-up period--a cognitive behavioral therapy for insomnia (CBT-I) called SHUTi (Sleep Healthy Using the Internet), SHUTi modified for Black women (SHUTi-BWHS), and patient education (PE) (usual treatment). This study aims to provide the much needed evidence to help Black women make informed decisions regarding treatment for their insomnia.

Conditions
COMPLETED
Health Literacy Assessment and Intervention to Reduce Disparities: FLIGHT/VIDAS II
Description

The purpose of this study will to be to evaluate the effects of a mobile intervention focused on improving the chronic disease self management skills of individuals with low health literacy. The intervention will provide information that culturally and linguistically tailored to participants' level of health literacy.

COMPLETED
Tailored Approach to Sleep Health Education: A Community Engaged Approach
Description

This study aims to develop educational tools and platforms to promote the transfer of sleep health information to blacks to foster adoption of healthful sleep practices.

ACTIVE_NOT_RECRUITING
Novel Strategies for Reducing Heart Disease Risk Disparities
Description

This Western Pennsylvania-based study will (1) improve cardiovascular risk stratification to identify high-risk populations, (2) identify disparities in cardiovascular risk based on race, socioeconomic status, and geographic location, (3) evaluate mechanisms for population differences in cardiovascular risk, and (4) implement a multidisciplinary community-based intervention program to decrease cardiovascular risk in high-risk populations. These goals, which are designed to eliminate ethnic and racial health disparities, are closely tied to the National Initiative to Eliminate Racial and Ethnic Disparities in Health and the nation's health promotion and disease prevention agenda established in Healthy People 2010. This is a prospective cohort study of 2,000 residents of the state of Pennsylvania with approximately equal representation of white and African American subjects. All participants will undergo assessments of traditional and nontraditional risk factors to identify and determine the mechanisms of population disparities in cardiovascular risk. 800 participants who are at intermediate or high risk of cardiovascular disease will be randomly assigned to either (1) usual care/"advice only"; or (2) a multidisciplinary behavioral modification program to determine the most effective approach to reduce or eliminate racial, socioeconomic and geographic disparities in cardiovascular risk. All participants will undergo long-term follow-up for cardiovascular events.

RECRUITING
Vascular Effects of Acute Sodium (VEAS) Study
Description

This IRB will cover a current clinical trial (NCT04244604) that was started at Auburn University (AU IRB#19-390), the Principal Investigator's prior institution, and is supported by his NIH Career Development Award (NHLBI K01HL147998). About nine out of ten Americans overconsume dietary salt. Compared to other racial groups, Black individuals are more prone to salt-sensitive hypertension and negative cardiovascular conditions associated with high salt intake. However, there is a critical need to determine the reasons behind and mechanisms that contribute to these racial disparities. Both acute (single meal) and chronic high-dietary sodium cause small but important increases in blood sodium concentration that are associated with altered blood pressure regulation and blood vessel dysfunction. However, racial differences in these measures have not been examined. This is important because Black individuals generally exhibit lower circulating concentrations of hormones (e.g., renin, aldosterone, angiotensin 2) that buffer changes in body sodium to regulate blood pressure, and this could make them more vulnerable to the negative effects of a high-sodium meal. Therefore, the purpose of this study is to determine whether there are racial differences in blood pressure regulation and blood flow after a high-sodium meal. The investigators will assess blood pressure regulation, blood vessel stiffness, and the blood vessel's ability to dilate before and after a high-salt meal and a low-salt control meal (both meals are low-salt tomato soup with varied added salt). The investigators will also collect blood and urine to measure sodium and determine biochemical changes that may be contributing to racial differences in cardiovascular function.