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Exploring Racial Disparities in Sleep Health and Neurocognitive Function

Not Applicable
Completed
Conditions
HIV Dementia
Interventions
Other: electroencephalography (EEG) and event related potentials (ERP)
Registration Number
NCT04015830
Lead Sponsor
University of Alabama, Tuscaloosa
Brief Summary

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+).

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • HIV+
  • Identify as AA or White
  • 50 years old or older
  • Speak English
Exclusion Criteria
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Older Adults with HIV (N = 60)electroencephalography (EEG) and event related potentials (ERP)African Americans and Whites age 50 and older
Primary Outcome Measures
NameTimeMethod
Subjective Sleep HealthDay 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 ProcessingDay 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 FunctionDay 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 MemoryDay 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 VisualizationDay 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

AttentionDay 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)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 OnsetDay 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 TimeDay 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 SeverityDay 1

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

Reaction TimeDay 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 Time7 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 OnsetDay 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 EfficiencyDay 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.

Secondary Outcome Measures
NameTimeMethod
Medication AdherenceDay 1

Simplified Medication Adherence Questionnaire is a measure of antiretroviral adherence, a participant is non-adherent if he/she has missed more than two doses within the last week or has not taken any medication for two complete days within the last three months

Instrumental Activities of Daily LivingDay 1

Brody and Lawton Instrumental Activities of Daily Living is a measure of instrumental activities of daily living, scores from 8 categories (ability to use telephone, shopping, food preparation, housekeeping, laundry, mode of transportation, responsibility of own medications, and ability to handle finances) are summed for a total score ranging from 0 (low function, dependent) to 8 (high function, independent) for women and 0 (low function, dependent) to 5 (high function, independent) for men

Everyday Problem Solving SkillsDay 1

Everyday Problems Test is a 42 iteme measure of everyday function in several categories (consumerism, meal preparation, medication use, financial management, transportation, phone usage, and housekeeping). Categorical scores are summed to calculate a total score ranging from 0 - 42 with greater scores indicating better everyday problems solving skills.

DepressionDay 1

Patient Health Questionnaire - 9 is a measure of depressive symptoms, 9-items are summed for a total score ranging from 0-27 with higher scores indicating more severe depressive symptoms

Health Related Quality of LifeDay 1

Medical Outcomes Study - HIV is a 35-item questionnaire with subscales (health perceptions, pain, physical functioning, role functioning, social functioning, cognitive functioning, mental health, energy, health distress, quality of life, and health transition. Subscales are summed for a total score between 0 and 100 with higher scores indicating better health or well-being.

Trial Locations

Locations (1)

University of Alabama

🇺🇸

Tuscaloosa, Alabama, United States

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