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
About this trial
This is an interventional basic science trial for HIV Dementia focused on measuring Sleep, Neurocognitive Disorders, HIV/AIDS, Aging
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
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
NCT ID
NCT04015830
First Posted
April 29, 2019
Last Updated
July 9, 2019
Sponsor
University of Alabama, Tuscaloosa
Collaborators
UAB Resource Centers for Minority Aging Research (RCMAR)
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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