Clinical trial NCT04015830: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Dementia
Keywords: Sleep
Neurocognitive Disorders
HIV/AIDS
Aging
Lead sponsor: University of Alabama, Tuscaloosa
Sponsor class: OTHER
Collaborators: name: UAB Resource Centers for Minority Aging Research (RCMAR)
First posted: 2019-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Subjective Sleep Health
timeFrame: Day 1
measure: Sleep Onset and Wake Time
timeFrame: 7 days
measure: Insomnia Severity
timeFrame: Day 1
measure: Speed of Processing
timeFrame: Day 1
measure: Executive Function
timeFrame: Day 1
measure: Attention
timeFrame: Day 1
measure: Spatial Visualization
timeFrame: Day 1
measure: Verbal Learning and Memory
timeFrame: Day 1
measure: Brief Visuospatial Memory Test (BVMT) (Recall and Delayed)
timeFrame: Day 1
measure: Sleep Onset
timeFrame: Day 1
measure: Total Sleep Time
timeFrame: Day 1
measure: Wake After Sleep Onset
timeFrame: Day 1
measure: Sleep Efficiency
timeFrame: Day 1
measure: Reaction Time
timeFrame: Day 1
Secondary outcomes:
measure: Medication Adherence
timeFrame: Day 1
measure: Instrumental Activities of Daily Living
timeFrame: Day 1
measure: Everyday Problem Solving Skills
timeFrame: Day 1
measure: Depression
timeFrame: Day 1
measure: Health Related Quality of Life
timeFrame: Day 1
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: University of Alabama
state: Alabama
Study officials:
affiliation: The University of Alabama
name: Shameka L Cody, PhD
role: PRINCIPAL_INVESTIGATOR
References: