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Exploring Racial Disparities in Sleep Health and Neurocognitive Function

Primary Purpose

HIV Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electroencephalography (EEG) and event related potentials (ERP)
Sponsored by
University of Alabama, Tuscaloosa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HIV Dementia focused on measuring Sleep, Neurocognitive Disorders, HIV/AIDS, Aging

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Older Adults with HIV (N = 60)

    Arm Description

    African Americans and Whites age 50 and older

    Outcomes

    Primary Outcome Measures

    Subjective Sleep Health
    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
    Sleep Onset and Wake Time
    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
    Insomnia Severity
    Insomnia Severity Index is a measure of insomnia. Total scores ranging from 0-28 with higher scores indicating more severe clinical insomnia
    Speed of Processing
    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
    Trails Making Test B is a measure of executive function (timed task) with greater time to complete task (in minutes) indicating poorer executive function
    Attention
    Paced Auditory Serial Addition Task is a measure of attention (50 items) with greater number of items correct indicating good attention span
    Spatial Visualization
    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
    Verbal Learning and Memory
    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.
    Brief Visuospatial Memory Test (BVMT) (Recall and Delayed)
    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
    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
    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.
    Wake After Sleep Onset
    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
    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.
    Reaction Time
    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.

    Secondary Outcome Measures

    Medication Adherence
    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 Living
    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 Skills
    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.
    Depression
    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 Life
    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.

    Full Information

    First Posted
    April 29, 2019
    Last Updated
    July 9, 2019
    Sponsor
    University of Alabama, Tuscaloosa
    Collaborators
    UAB Resource Centers for Minority Aging Research (RCMAR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04015830
    Brief Title
    Exploring Racial Disparities in Sleep Health and Neurocognitive Function
    Official Title
    Exploring Racial Disparities in Sleep Health and Neurocognitive Function in Older Adults With HIV
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2019 (Anticipated)
    Primary Completion Date
    June 30, 2020 (Anticipated)
    Study Completion Date
    June 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama, Tuscaloosa
    Collaborators
    UAB Resource Centers for Minority Aging Research (RCMAR)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Dementia
    Keywords
    Sleep, Neurocognitive Disorders, HIV/AIDS, Aging

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Older Adults with HIV (N = 60)
    Arm Type
    Experimental
    Arm Description
    African Americans and Whites age 50 and older
    Intervention Type
    Other
    Intervention Name(s)
    electroencephalography (EEG) and event related potentials (ERP)
    Intervention Description
    This is an exploratory study of EEG/ERP measures in older African American and Whites with HIV
    Primary Outcome Measure Information:
    Title
    Subjective Sleep Health
    Description
    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
    Time Frame
    Day 1
    Title
    Sleep Onset and Wake Time
    Description
    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
    Time Frame
    7 days
    Title
    Insomnia Severity
    Description
    Insomnia Severity Index is a measure of insomnia. Total scores ranging from 0-28 with higher scores indicating more severe clinical insomnia
    Time Frame
    Day 1
    Title
    Speed of Processing
    Description
    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
    Time Frame
    Day 1
    Title
    Executive Function
    Description
    Trails Making Test B is a measure of executive function (timed task) with greater time to complete task (in minutes) indicating poorer executive function
    Time Frame
    Day 1
    Title
    Attention
    Description
    Paced Auditory Serial Addition Task is a measure of attention (50 items) with greater number of items correct indicating good attention span
    Time Frame
    Day 1
    Title
    Spatial Visualization
    Description
    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
    Time Frame
    Day 1
    Title
    Verbal Learning and Memory
    Description
    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.
    Time Frame
    Day 1
    Title
    Brief Visuospatial Memory Test (BVMT) (Recall and Delayed)
    Description
    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.
    Time Frame
    Day 1
    Title
    Sleep Onset
    Description
    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.
    Time Frame
    Day 1
    Title
    Total Sleep Time
    Description
    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.
    Time Frame
    Day 1
    Title
    Wake After Sleep Onset
    Description
    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.
    Time Frame
    Day 1
    Title
    Sleep Efficiency
    Description
    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.
    Time Frame
    Day 1
    Title
    Reaction Time
    Description
    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.
    Time Frame
    Day 1
    Secondary Outcome Measure Information:
    Title
    Medication Adherence
    Description
    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
    Time Frame
    Day 1
    Title
    Instrumental Activities of Daily Living
    Description
    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
    Time Frame
    Day 1
    Title
    Everyday Problem Solving Skills
    Description
    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.
    Time Frame
    Day 1
    Title
    Depression
    Description
    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
    Time Frame
    Day 1
    Title
    Health Related Quality of Life
    Description
    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.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shameka L Cody, PhD
    Phone
    2053483374
    Email
    slcody@ua.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shameka L Cody, PhD
    Organizational Affiliation
    The University of Alabama
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Exploring Racial Disparities in Sleep Health and Neurocognitive Function

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