HIV DementiaNCT04015830
Exploring Racial Disparities in Sleep Health and Neurocognitive Function
A study testing electroencephalography (EEG) and event related potentials (ERP) in people with HIV Dementia, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Dementia
- What is being tested?
- electroencephalography (EEG) and event related potentials (ERP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV+
- Identify as AA or White
- 50 years old or older
- Speak English
Who cannot join
- 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
Show all 12Show fewer
- Significant neuromedical comorbidities (e.g., schizophrenia)
- Currently taking Efavirenz
- Moderate to severe sleep apnea
- Restless leg syndrome
- Narcolepsy
- Left handedness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Racial Disparities in Sleep Health and Neurocognitive Function in Older Adults With HIV
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+).
Read the 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.
- Conditions
- HIV Dementia
- Being tested
- electroencephalography (EEG) and event related potentials (ERP)
- Keywords
- Sleep, Neurocognitive Disorders, HIV/AIDS, Aging
- Medical subject headings
- AIDS Dementia Complex, Neurocognitive Disorders, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroencephalography (EEG) and event related potentials (ERP)Other
This is an exploratory study of EEG/ERP measures in older African American and Whites with HIV
| Study group | Role | What they receive |
|---|---|---|
| Older Adults with HIV (N = 60) | Experimental | African Americans and Whites age 50 and older Receives: Other: electroencephalography (EEG) and event related potentials (ERP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
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
Measured: 7 days
Insomnia Severity
Insomnia Severity Index is a measure of insomnia. Total scores ranging from 0-28 with higher scores indicating more severe clinical insomnia
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
Attention
Paced Auditory Serial Addition Task is a measure of attention (50 items) with greater number of items correct indicating good attention span
Measured: Day 1
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
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
Secondary outcomes (5)
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
Measured: Day 1
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
Measured: Day 1
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.
Measured: Day 1
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
Measured: Day 1
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Jan 2021
- Primary completion1 Dec 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- UAB Resource Centers for Minority Aging Research (RCMAR)
- Responsible party
- Principal investigator, Shameka L. Cody, University of Alabama, Tuscaloosa
- Investigators
- Shameka L Cody, PhD, Principal investigator, The University of Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015830
- Sponsor's protocol ID
- UATuscaloosa
- Status last verified
- May 2024
- First submitted
- 29 Apr 2019
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Racial Disparities in Sleep Health and Neurocognitive Function in Older Adults With HIV
- ClinicalTrials.gov ID
- NCT04015830
- Acronym / sponsor ID
- UATuscaloosa
- Conditions
- HIV Dementia
- Keywords
- Sleep, Neurocognitive Disorders, HIV/AIDS, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- UAB Resource Centers for Minority Aging Research (RCMAR)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Adults with HIV (N = 60) | Experimental | Other: electroencephalography (EEG) and event related potentials (ERP)African Americans and Whites age 50 and older |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV+
- Identify as AA or White
- 50 years old or older
- Speak English
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroencephalography (EEG) and event related potentials (ERP)This is an exploratory study of EEG/ERP measures in older African American and Whites with HIV | Other | Older Adults with HIV (N = 60) |
Primary outcome
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.
5 secondary outcomes
Medication Adherence
Time frame: Day 1
Instrumental Activities of Daily Living
Time frame: Day 1
Everyday Problem Solving Skills
Time frame: Day 1
Depression
Time frame: Day 1
Health Related Quality of Life
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shameka L Cody, PhD principal investigator
The University of Alabama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalography (EEG) and event related potentials (ERP) in people with HIV Dementia, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Sleep Health (time frame: Day 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.