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出境医 / 临床实验 / Exploring Racial Disparities in Sleep Health and Neurocognitive Function

Exploring Racial Disparities in Sleep Health and Neurocognitive Function

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+).

Condition or disease Intervention/treatment Phase
HIV Dementia Other: electroencephalography (EEG) and event related potentials (ERP) Not Applicable

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exploring Racial Disparities in Sleep Health and Neurocognitive Function in Older Adults With HIV
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Older Adults with HIV (N = 60)
African Americans and Whites age 50 and older
 Other: electroencephalography (EEG) and event related potentials (ERP)
This is an exploratory study of EEG/ERP measures in older African American and Whites with HIV
Outcome Measures
Primary Outcome Measures :
  1. Subjective Sleep Health [ Time Frame: 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

  2. Sleep Onset and Wake Time [ Time Frame: 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

  3. Insomnia Severity [ Time Frame: Day 1 ]
    Insomnia Severity Index is a measure of insomnia. Total scores ranging from 0-28 with higher scores indicating more severe clinical insomnia

  4. Speed of Processing [ Time Frame: 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

  5. Executive Function [ Time Frame: 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

  6. Attention [ Time Frame: Day 1 ]
    Paced Auditory Serial Addition Task is a measure of attention (50 items) with greater number of items correct indicating good attention span

  7. Spatial Visualization [ Time Frame: 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

  8. Verbal Learning and Memory [ Time Frame: 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.

  9. Brief Visuospatial Memory Test (BVMT) (Recall and Delayed) [ Time Frame: 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.

  10. Sleep Onset [ Time Frame: 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.

  11. Total Sleep Time [ Time Frame: 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.

  12. Wake After Sleep Onset [ Time Frame: 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.

  13. Sleep Efficiency [ Time Frame: 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.

  14. Reaction Time [ Time Frame: 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.


Secondary Outcome Measures :
  1. Medication Adherence [ Time Frame: Day 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

  2. Instrumental Activities of Daily Living [ Time Frame: Day 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

  3. Everyday Problem Solving Skills [ Time Frame: Day 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.

  4. Depression [ Time Frame: Day 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

  5. Health Related Quality of Life [ Time Frame: Day 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Shameka L Cody, PhD 2053483374 slcody@ua.edu

Sponsors and Collaborators
University of Alabama, Tuscaloosa
UAB Resource Centers for Minority Aging Research (RCMAR)
Investigators
Layout table for investigator information
Principal Investigator: Shameka L Cody, PhD The University of Alabama
Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date July 11, 2019
Estimated Study Start Date  ICMJE August 1, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Subjective Sleep Health [ Time Frame: 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
  • Sleep Onset and Wake Time [ Time Frame: 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
  • Insomnia Severity [ Time Frame: Day 1 ]
    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 [ Time Frame: 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 [ Time Frame: 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
  • Attention [ Time Frame: Day 1 ]
    Paced Auditory Serial Addition Task is a measure of attention (50 items) with greater number of items correct indicating good attention span
  • Spatial Visualization [ Time Frame: 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
  • Verbal Learning and Memory [ Time Frame: 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.
  • Brief Visuospatial Memory Test (BVMT) (Recall and Delayed) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Wake After Sleep Onset [ Time Frame: 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 [ Time Frame: 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.
  • Reaction Time [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Medication Adherence [ Time Frame: Day 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 Living [ Time Frame: Day 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 Skills [ Time Frame: Day 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.
  • Depression [ Time Frame: Day 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 Life [ Time Frame: Day 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploring Racial Disparities in Sleep Health and Neurocognitive Function
Official Title  ICMJE Exploring Racial Disparities in Sleep Health and Neurocognitive Function in Older Adults With HIV
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE HIV Dementia
Intervention  ICMJE Other: electroencephalography (EEG) and event related potentials (ERP)
This is an exploratory study of EEG/ERP measures in older African American and Whites with HIV
Study Arms  ICMJE Experimental: Older Adults with HIV (N = 60)
African Americans and Whites age 50 and older
Intervention: Other: electroencephalography (EEG) and event related potentials (ERP)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Shameka L Cody, PhD 2053483374 slcody@ua.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015830
Other Study ID Numbers  ICMJE UATuscaloosa
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shameka L. Cody, University of Alabama, Tuscaloosa
Study Sponsor  ICMJE University of Alabama, Tuscaloosa
Collaborators  ICMJE UAB Resource Centers for Minority Aging Research (RCMAR)
Investigators  ICMJE
Principal Investigator: Shameka L Cody, PhD The University of Alabama
PRS Account University of Alabama, Tuscaloosa
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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