Exploring Racial Disparities in Sleep Health and Neurocognitive Function
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04015830|
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Dementia||Other: electroencephalography (EEG) and event related potentials (ERP)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Exploring Racial Disparities in Sleep Health and Neurocognitive Function in Older Adults With HIV|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Older Adults with HIV (N = 60)
African Americans and Whites age 50 and older
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
- 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.
- Medication Adherence [ Time Frame: Day 1 ]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 [ Time Frame: Day 1 ]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 [ Time Frame: Day 1 ]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 [ Time Frame: Day 1 ]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 [ Time Frame: Day 1 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015830
|Contact: Shameka L Cody, PhDemail@example.com|
|Principal Investigator:||Shameka L Cody, PhD||The University of Alabama|