Exploring Racial Disparities in Sleep Health and Neurocognitive Function

NCT04015830 | Completed

• 1 other identifier: UATuscaloosa
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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+).

Conditions

HIV Dementia

Keywords

Sleep; Neurocognitive Disorders; HIV/AIDS; Aging

Outcome Measures

Primary Outcomes (14)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Medication Adherence

  Day 1

• Instrumental Activities of Daily Living

  Day 1

• Everyday Problem Solving Skills

  Day 1

• Depression

  Day 1

• Health Related Quality of Life

  Day 1

Study Arms (1)

Older Adults with HIV (N = 60)

EXPERIMENTAL

African Americans and Whites age 50 and older

Other: electroencephalography (EEG) and event related potentials (ERP)

Interventions

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

Older Adults with HIV (N = 60)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+
• Identify as AA or White
• years old or older
• Speak English

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• UAB Resource Centers for Minority Aging Research (RCMAR): collaborator

Study Sites (1)

University of Alabama

Tuscaloosa, Alabama, 35401, United States

Location

MeSH Terms

Conditions

AIDS Dementia Complex; Neurocognitive Disorders; Acquired Immunodeficiency Syndrome

Interventions

Evoked Potentials

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mental Disorders; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Shameka L Cody, PhD

  The University of Alabama

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: July 11, 2019
• Study Start: January 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)