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临床试验/NCT04015830
NCT04015830已完成不适用

Exploring Racial Disparities in Sleep Health and Neurocognitive Function in Older Adults With HIV

University of Alabama, Tuscaloosa2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Subjective Sleep Health

研究概览

简要总结

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+).

详细描述

This study is designed with two aims: Aim 1a: To explore differences in sleep health between older HIV+ AA and Whites. 1b: To explore differences in domain-specific neurocognitive impairments between older HIV+ AA and Whites. Aim 2a: To explore the relationship between sleep health and neurocognitive function. 2b: To explore the relationship between sleep health and cART adherence. 2c: To explore mediation effects of cART adherence between sleep health and neurocognitive function. This is the first study to explore racial disparities in sleep health and neurocognitive function, using EEG/ERP metrics, among older HIV+ adults. There are two phases in this study: Phase I which consists of neurocognitive testing and sleep assessments with actigraphy, and Phase II which consist of a 20-30 min EEG. Measurements of electrical brain activity will be captured while participants engage in an Attention Network Test which measures executive function, attention, and speed of processing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Identify as AA or White
  • 50 years old or older
  • Speak English

排除标准

  • Alzheimer's disease or dementia
  • Severe neurocognitive impairment (>7 errors on the Short Portable Mental Status Questionnaire)
  • Deaf or blind
  • Currently undergoing radiation/chemotherapy
  • Brain trauma with loss of consciousness greater than 30 minutes
  • A learning disability
  • Significant neuromedical comorbidities (e.g., schizophrenia)
  • Currently taking Efavirenz
  • Moderate to severe sleep apnea
  • Restless leg syndrome
  • Narcolepsy
  • Left handedness

结局指标

主要结局

Subjective Sleep Health

时间窗: Day 1

Pittsburgh Sleep Quality Index (PSQI), the components are summed to create a global score between 0 and 21, with a global score of 5 or greater indicating poor sleep quality

Speed of Processing

时间窗: Day 1

Trails Making A Test is a measure of speed of processing (timed task) with greater time to complete task (in minutes) indicating poorer speed of processing

Executive Function

时间窗: Day 1

Trails Making Test B is a measure of executive function (timed task) with greater time to complete task (in minutes) indicating poorer executive function

Verbal Learning and Memory

时间窗: Day 1

Hopkins Verbal Learning Test-Revised (Recall and Delayed) is a measure of verbal learning and memory. Three learning trials are summed to calculate a total recall score (maximum score is 36) with greater scores indicating better verbal learning and memory. The delayed recall score is the number of items correct (maximum score is 12) after 25-minutes with greater scores indicating better delayed recall.

Spatial Visualization

时间窗: Day 1

Wechsler Adult Intelligence Scale (WAIS III) is a measure of spatial visualization. Scores on items are summed for a maximum score of 21 with greater scores indicating better spatial visualization

Attention

时间窗: Day 1

Paced Auditory Serial Addition Task is a measure of attention (50 items) with greater number of items correct indicating good attention span

Brief Visuospatial Memory Test (BVMT) (Recall and Delayed)

时间窗: Day 1

Measure of visuospatial memory, three learning trials are summed to calculate a total recall score (maximum score is 36) with greater scores indicating better visuospatial memory. The delayed recall score is the number of items correct (maximum score is 12) after 25-minutes with greater scores indicating better delayed visuospatial memory.

Sleep Onset

时间窗: Day 1

Actigraphy will measure sleep onset which is the time (in minutes) it takes to fall asleep with longer times indicating worse sleep onset. Time (in minutes) is averaged over 7 days.

Total Sleep Time

时间窗: Day 1

Actigraphy will measure total sleep time which is the number of sleep hours with lesser hours indicating worse sleep deficiency. Time (in hours) is averaged over 7 days.

Insomnia Severity

时间窗: Day 1

Insomnia Severity Index is a measure of insomnia. Total scores ranging from 0-28 with higher scores indicating more severe clinical insomnia

Reaction Time

时间窗: Day 1

The Attention Network Test is a computerized measure of reaction times (in milliseconds) to presented stimuli over several trials. Mean reaction time is calculated by averaging the reaction times over 7 trials, with longer mean reaction times indicating poorer attention.

Sleep Onset and Wake Time

时间窗: 7 days

A sleep diary will be used to evaluate sleep onset and wake time. Participant will be asked to document the time they fall asleep and the time they wake up

Wake After Sleep Onset

时间窗: Day 1

Actigraphy will measure wake after sleep onset which is the number of awakenings after sleep onset with greater number of episodes indicating sleep fragmentation/poorer sleep.

Sleep Efficiency

时间窗: Day 1

Actigraphy will measure sleep efficiency which is the percentage of time spent sleep while in bed. It is calculated by dividing the total sleep time (in minutes) by the total amount of time in bed (in minutes) with 85-95% indicating good sleep efficiency.

次要结局

  • Instrumental Activities of Daily Living(Day 1)
  • Medication Adherence(Day 1)
  • Everyday Problem Solving Skills(Day 1)
  • Depression(Day 1)
  • Health Related Quality of Life(Day 1)

研究者

发起方
University of Alabama, Tuscaloosa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shameka L. Cody

Assistant Professor

University of Alabama, Tuscaloosa

研究点 (2)

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