The overall objective of this application is to investigate the impact of insomnia on pain, physical functioning, and inflammation in people living with HIV. The two aims of this study to determine 1) whether insomnia promotes increased sensitivity and inflammatory reactivity to pain stimuli, and 2) if weekly fluctuations in insomnia burden drive changes in inflammation, pain severity, and physical functioning in people living with HIV. This research could help confirm insomnia as a therapeutic target for the suppression of pain and inflammation in people living with HIV.
Experimental session 1 Resting Blood Pressure and Body Mass Index will be assessed. Participants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test. Study staff will administer the Structured Interview for Sleep Disorders and administer the Rapid Estimation of Adult Literacy Measure-Short Form (REALM-SF) to determine health literacy. The night of Experimental Session 1 participant will be using a Resmed ApneaLink Air device (Resmed, San Diego, CA), to identify apnea and hypopnea and calculate an apnea hypopnea index. Between Experimental Session 1 and Experimental Session 2 Sleep assessment: Sleep data will be collected by participants in their own homes using objective and subjective measures of their sleep. Participant instructions for how to collect and record their own sleep data will be provided at the end of study session 1. Participant will be provided with a watch-like device to wear on wrist for 7 consecutive days and nights. This watch measures physical activity and sleep. Experimental Session 2 Resting Blood Pressure and temperature will be assessed. A sample of urine will be taken to test for illicit substances that might affect the study's results. Experimental session 2 will take place in the Center for Clinical and Translational Science (CCTS) Clinical Research Unit (CRU). A clinical Research Unit (CRU) nurse will place an intravenous (IV) cannula (small plastic tube) in the arm using a needle to draw blood at the beginning of the session and then an additional four times across the study for a total of five blood draws. Participants will complete multiple questionnaires to measure health, and experience with insomnia, pain, mood and emotions, experiences with stigma and discrimination, and how participant thinks and feels about things. All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 3-4 hours. Blood will be processed and stored and then used to measure inflammation. Weekly Follow-up Sessions Participants will then complete a battery of ecologically valid movement tasks that include: 1) Performance Battery (SPPB) which includes sitting in a chair, transitioning to a standing position, balancing tests and gait speed, and the Timed Up and Go test (TUG). A clinical Research Unit (CRU) nurse will draw a quick sample of approximately 20 milliliters from the participants arm using a butterfly needle so that CRU nurse can collect blood during the beginning of each visit.
Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R) - is a semi structured interview for diagnosing sleep disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
Home Sleep Test (HST) will measure airflow (i.e., nasal pressure) using a nasal cannula and oxygen saturation to identify apnea and hypopnea and calculate an apnea hypopnea index (AHI; number of apnea and hypopnea per hour).
UAB
Birmingham, Alabama, United States
Pro-Inflammatory markers
TNF-a, IL-6, IL-12, IL-18, C-reactive protein, sCD14/163, D-dimer and IFN-gamma assays will be performed on the blood to identify levels of pro-inflammatory markers.
Time frame: Baseline up to 8 weeks
Anti-Inflammatory markers
IFN-a, TGF-B, IL4, IL-10 and IL-13 assays will be performed on the blood to identify levels of anti-inflammatory markers.
Time frame: Baseline up to 8 weeks
Oxidative Stress markers
Mitochondrial DNA damage, Damage associated molecular patterns (DAMPS) and Cortisolassays will be performed on the blood to identify levels of anti-inflammatory markers.
Time frame: Baseline up to 8 weeks
Pain threshold
Pain threshold refers to the intensity at which a stimulus is first perceived as painful. Heat stimuli will be delivered using a computer-controlled thermal stimulation system with a 30 millimeter X 30 millimeter probe. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain threshold, participants will be instructed to press the button when the sensation "first becomes painful"
Time frame: Baseline up to 1 week
Pain tolerance
Pain tolerance refers to the maximum amount of pain produced by a stimulus that a person is able/willing to tolerate. Heat stimuli will again be delivered using the computer-controlled thermal stimulation system. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain tolerance, participants will be instructed to press the button when they are "no longer willing to tolerate" the painful sensation.
Time frame: Baseline up to 1 week
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Study Type
OBSERVATIONAL
Enrollment
171
All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
Participants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test to confirm negative status.
Participants who have an HIV positive status will have blood tested for cluster of differentiation 4 (CD4) and Viral load to confirm positive status.
Punctate Stimuli
Monofilament touch test refers to the maximum amount of pain produced by a stimulus that a person is able/willing to tolerate. Participants will be asked to rate their pain after being stimulated either once or ten times with vonfrey filament, or until they can no longer tolerate" the painful sensation.
Time frame: Baseline up to 1 week
Temporal summation of pain
Temporal summation of pain refers to a form of endogenous pain facilitation characterized by the perception of increased pain despite constant or even reduced peripheral afferent input. Temporal summation is presumed to be the psychophysical manifestation of wind-up. Wind-up is a phenomenon where repetitive stimulation of C primary afferents at rates greater than 0.3 Hertz produces a slowly increasing response of second-order neurons in the spinal cord. A series of 5 heat pulses will be repeated every two seconds starting at a baseline temperature of 40 and participants will be asked to rate how painful each peak of the pulse feels to them using a pain rating of 0-100 (0 no pain at all to 100 the most intense pain imaginable). These heat pulses will be repeated randomly at three different temperatures peaking at 44, 46, and 48 degrees in Celsius.
Time frame: Baseline up to 1 week
Conditioned pain modulation
A routinely used quantitative sensory testing protocol for the measurement of endogenous pain inhibition, which refers to the reduction in pain from one stimulus (the test stimulus) produced by the application of a second pain stimulus (the conditioning stimulus). The conditioning stimulus will be the cold pressor task (Thermo Scientific) applied to the non-dominant hand. For this procedure the cold water will be maintained at 10C and participants will keep their hand immersed for 60 seconds. Upon removal of the hand, a mechanical pressure stimulus will be applied. The pressure stimulus used is a handheld, digital pressure algometer (Algomed, Medoc, Ramat Yishai, Israel) to assess pressure pain applied to the dominant forearm and ipsilateral trapezius by gradually increasing pressure at a rate of 30 kiloPascals (maximum 1000 kiloPascals) per second until participants indicate when the increasing pressure first becomes painful by pressing a button on a device they will be holding.
Time frame: Baseline up to 1 week
Actigraph Sleep Measurement
A light weight and compact watch-like device used for objective measurement of sleep. The device will be worn for 7 consecutive days/nights and will track physical activity, falling asleep and waking events, and includes an integrated light sensor for recording photopic light.
Time frame: Baseline up to 8 weeks
Weekly Sleep Diaries
A sleep diary including 15 daily questions will be filled out every day for seven days including questions about a participants nightly sleep experiences.
Time frame: Baseline up to 8 weeks
Weekly Caffeine Diaries
A caffeine dairy including different types of caffeine generally available for the participants to record their daily caffeine consumption of for seven days.
Time frame: Baseline up to 8 weeks
Short Physical Performance Battery
The SPPB consists of 3 individual sub-tests - standing balance (participants are asked to stand in 3 easy stances for 10 seconds), 4-meter gait speed (participants are asked to walk a steady pace in a straight line for 4-meters) and 5-repetition sit-to-stand (particpants are asked to stand up and sit back down in a stable chair up to 5 times). All 3 are simple and quick to perform in the outpatient setting and require only limited equipment; participants are asked to rate difficulty 0-100 (0 no difficulty and 100 being the most difficult imaginable) and pain 0-100 (0 no pain and 100 being the most pain imaginable).
Time frame: Week 2 up to 8 weeks