The Impact of Insomnia on Pain in HIV
HIPPI
2 other identifiers
observational
171
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
March 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedSeptember 17, 2025
September 1, 2025
5.6 years
February 20, 2020
September 10, 2025
Conditions
Outcome Measures
Primary Outcomes (11)
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.
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.
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.
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"
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.
Baseline up to 1 week
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.
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.
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.
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.
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.
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.
Baseline up to 8 weeks
Secondary Outcomes (1)
Short Physical Performance Battery
Week 2 up to 8 weeks
Other Outcomes (26)
Timed Up and Go (TUG) Task
Week 2 up to 8 weeks
Munich Chrono Type Questionnaires (MCTQ)
Baseline
Insomnia Severity Index (ISI)
Baseline up to 8 weeks
- +23 more other outcomes
Study Arms (4)
HIV and Insomnia
Participants will test positive for HIV and Insomnia.
HIV Without Insomnia
Participants will test positive for HIV and test negative for Insomnia.
Non HIV with Insomnia
Participants will test negative for HIV and test positive for Insomnia.
Non HIV Without Insomnia
Participants will test negative for HIV and test negative for Insomnia.
Interventions
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).
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.
Eligibility Criteria
120 individuals with HIV (60 with insomnia \& 60 without insomnia) as well as a group of 120 individuals without HIV as Controls (60 with insomnia \& 60 without insomnia), for a total sample size of 240 individuals.
You may qualify if:
- HIV with Insomnia
- Confirmed HIV diagnosis
- currently a patient in the University of Alabama (UAB) 1917 HIV Clinic.
- must be currently receiving stable antiretroviral therapy (ART).
- Meets the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty.
- HIV Without Insomnia
- Confirmed HIV diagnosis
- currently a patient in the University of Alabama (UAB) 1917 HIV Clinic.
- must be currently receiving stable antiretroviral therapy (ART).
- Does not meet the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty.
- Non HIV with Insomnia
- Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic.
- Meets DSM-5 diagnostic criteria for insomnia including sleep difficulty.
- Non HIV Without Insomnia
- Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic.
- +1 more criteria
You may not qualify if:
- concurrent medical conditions that could confound
- interpretation of sleep
- pain
- inflammatory issues or coexisting diseases
- Systemic rheumatic disease/condition
- uncontrolled hypertension (i.e., BP \> 150/95)
- circulatory disorders (e.g., Reynaud's disease)
- history of heart disease or cardiac events
- history of cancer
- asthma AND use of an inhaler
- history of seizures
- history of stroke or other neurological disorder
- pregnancy
- core body temperature \> 100 degrees Fahrenheit as this could indicate acute infection with fever; (k)
- unwilling to provide blood for this study
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UAB
Birmingham, Alabama, 35294, United States
Related Publications (3)
Tenorio AR, Zheng Y, Bosch RJ, Krishnan S, Rodriguez B, Hunt PW, Plants J, Seth A, Wilson CC, Deeks SG, Lederman MM, Landay AL. Soluble markers of inflammation and coagulation but not T-cell activation predict non-AIDS-defining morbid events during suppressive antiretroviral treatment. J Infect Dis. 2014 Oct 15;210(8):1248-59. doi: 10.1093/infdis/jiu254. Epub 2014 May 1.
PMID: 24795473BACKGROUNDGoodin BR, Owens MA, Yessick LR, Rainey RL, Okunbor JI, White DM, Mushatt KA, Harmon OA, Heath SL, Merlin JS. Detectable Viral Load May Be Associated with Increased Pain Sensitivity in Persons Living with HIV: Preliminary Findings. Pain Med. 2017 Dec 1;18(12):2289-2295. doi: 10.1093/pm/pnx057.
PMID: 28398572BACKGROUNDMerlin JS, Westfall AO, Heath SL, Goodin BR, Stewart JC, Sorge RE, Younger J. Brief Report: IL-1beta Levels Are Associated With Chronic Multisite Pain in People Living With HIV. J Acquir Immune Defic Syndr. 2017 Aug 1;75(4):e99-e103. doi: 10.1097/QAI.0000000000001377.
PMID: 28328552BACKGROUND
Biospecimen
Serum and plasma
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Burel R Goodin, PHd
University of Alabama at Birmingham
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 20, 2020
First Posted
March 6, 2020
Study Start
January 1, 2020
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
September 17, 2025
Record last verified: 2025-09