Exploring Racial Disparities in Sleep Health and Neurocognitive Function

HIV Dementia Clinical Trial

Official title:

Exploring Racial Disparities in Sleep Health and Neurocognitive Function in Older Adults With HIV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04015830
• Other study ID #: UATuscaloosa
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: May 2024
• Source: University of Alabama, Tuscaloosa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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+).

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 1, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AIDS Dementia Complex
• HIV Dementia

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama	Tuscaloosa	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama, Tuscaloosa	UAB Resource Centers for Minority Aging Research (RCMAR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1
Primary	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	7 days
Primary	Insomnia Severity	Insomnia Severity Index is a measure of insomnia. Total scores ranging from 0-28 with higher scores indicating more severe clinical insomnia	Day 1
Primary	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	Day 1
Primary	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	Day 1
Primary	Attention	Paced Auditory Serial Addition Task is a measure of attention (50 items) with greater number of items correct indicating good attention span	Day 1
Primary	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	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Secondary	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	Day 1
Secondary	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	Day 1
Secondary	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.	Day 1
Secondary	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	Day 1
Secondary	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.	Day 1