HIVHIPPINCT04298658
The Impact of Insomnia on Pain in HIV
An observational study of HIV and Insomnia, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- What is being tested?
- Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised, Resmed ApneaLink Air device (Resmed, San Diego, CA). and Quantitative Sensory testing (QST)
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 16Show fewer
- 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.
- Does not meets DSM-5 diagnostic criteria for insomnia including sleep difficulty.
Who cannot join
- 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)
Show all 17Show fewer
- 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
- non-English speaking
- recent injury or surgical procedure within past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Insomnia on Pain, Physical Function, and Inflammation in HIV
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.
Read the detailed description
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.
- Being tested
- Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised, Resmed ApneaLink Air device (Resmed, San Diego, CA)., Quantitative Sensory testing (QST), OraQuick Advance Rapid HIV 1/2 Swab test, Cluster of Differentiation 4 (CD4) and Viral load
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revisedDiagnostic test
Also called Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R)
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)
Resmed ApneaLink Air device (Resmed, San Diego, CA).Diagnostic test
Also called Home Sleep Test
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).
Quantitative Sensory testing (QST)Other
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.
OraQuick Advance Rapid HIV 1/2 Swab testDiagnostic test
Also called OraQuick
Participants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test to confirm negative status.
Cluster of Differentiation 4 (CD4) and Viral loadDiagnostic test
Participants who have an HIV positive status will have blood tested for cluster of differentiation 4 (CD4) and Viral load to confirm positive status.
| Study group | Role | What they receive |
|---|---|---|
| HIV and Insomnia | Participants will test positive for HIV and Insomnia. Receives: Diagnostic Test: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised; Diagnostic Test: Resmed ApneaLink Air device (Resmed, San Diego, CA).; Other: Quantitative Sensory testing (QST); Diagnostic Test: Cluster of Differentiation 4 (CD4) and Viral load | |
| HIV Without Insomnia | Participants will test positive for HIV and test negative for Insomnia. Receives: Diagnostic Test: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised; Diagnostic Test: Resmed ApneaLink Air device (Resmed, San Diego, CA).; Other: Quantitative Sensory testing (QST); Diagnostic Test: Cluster of Differentiation 4 (CD4) and Viral load | |
| Non HIV with Insomnia | Participants will test negative for HIV and test positive for Insomnia. Receives: Diagnostic Test: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised; Diagnostic Test: Resmed ApneaLink Air device (Resmed, San Diego, CA).; Other: Quantitative Sensory testing (QST); Diagnostic Test: OraQuick Advance Rapid HIV 1/2 Swab test | |
| Non HIV Without Insomnia | Participants will test negative for HIV and test negative for Insomnia. Receives: Diagnostic Test: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised; Diagnostic Test: Resmed ApneaLink Air device (Resmed, San Diego, CA).; Other: Quantitative Sensory testing (QST); Diagnostic Test: OraQuick Advance Rapid HIV 1/2 Swab test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 8 weeks
Secondary outcomes (1)
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).
Measured: Week 2 up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Jan 2020
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Burel Goodin, University of Alabama at Birmingham
- Investigators
- Burel R Goodin, PHd, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298658
- Sponsor's protocol ID
- 300003778
- Other IDs
- 1R01HL147603-01
- Acronym
- HIPPI
- Status last verified
- Sep 2025
- First submitted
- 20 Feb 2020
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24795473Goodin 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.
PubMed 28398572Merlin 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.
PubMed 28328552Webb CK, Gilstrap Wilson SR, Hobson JM, Stallworth HN, White-Gilliam DM, Owens MA, Cody SL, Justin Thomas S, Sorge RE, Goodin BR. Living with HIV and Insomnia: Implications for sleep quality, experimental pain sensitivity, and clinical pain severity. J Pain. 2026 Jul;44:106283. doi: 10.1016/j.jpain.2026.106283. Epub 2026 Apr 15.
PubMed 41997468
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Insomnia on Pain, Physical Function, and Inflammation in HIV
- ClinicalTrials.gov ID
- NCT04298658
- Acronym / sponsor ID
- HIPPI / 300003778
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HIV and Insomnia | – | Diagnostic Test: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised, Diagnostic Test: Resmed ApneaLink Air device (Resmed, San Diego, CA)., Other: Quantitative Sensory testing (QST), Diagnostic Test: Cluster of Differentiation 4 (CD4) and Viral loadParticipants will test positive for HIV and Insomnia. |
| HIV Without Insomnia | – | Diagnostic Test: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised, Diagnostic Test: Resmed ApneaLink Air device (Resmed, San Diego, CA)., Other: Quantitative Sensory testing (QST), Diagnostic Test: Cluster of Differentiation 4 (CD4) and Viral loadParticipants will test positive for HIV and test negative for Insomnia. |
| Non HIV with Insomnia | – | Diagnostic Test: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised, Diagnostic Test: Resmed ApneaLink Air device (Resmed, San Diego, CA)., Other: Quantitative Sensory testing (QST), Diagnostic Test: OraQuick Advance Rapid HIV 1/2 Swab testParticipants will test negative for HIV and test positive for Insomnia. |
| Non HIV Without Insomnia | – | Diagnostic Test: Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised, Diagnostic Test: Resmed ApneaLink Air device (Resmed, San Diego, CA)., Other: Quantitative Sensory testing (QST), Diagnostic Test: OraQuick Advance Rapid HIV 1/2 Swab testParticipants will test negative for HIV and test negative for Insomnia. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (17 listed)
- concurrent medical conditions that could confound
- interpretation of sleep
- pain
- inflammatory issues or coexisting diseases
- Systemic rheumatic disease/condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revisedAlso: Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R)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) | Diagnostic test | HIV Without Insomnia, HIV and Insomnia, Non HIV Without Insomnia, Non HIV with Insomnia |
| Resmed ApneaLink Air device (Resmed, San Diego, CA).Also: Home Sleep TestHome 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). | Diagnostic test | HIV Without Insomnia, HIV and Insomnia, Non HIV Without Insomnia, Non HIV with Insomnia |
| Quantitative Sensory testing (QST)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. | Other | HIV Without Insomnia, HIV and Insomnia, Non HIV Without Insomnia, Non HIV with Insomnia |
| OraQuick Advance Rapid HIV 1/2 Swab testAlso: OraQuickParticipants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test to confirm negative status. | Diagnostic test | Non HIV Without Insomnia, Non HIV with Insomnia |
| Cluster of Differentiation 4 (CD4) and Viral loadParticipants who have an HIV positive status will have blood tested for cluster of differentiation 4 (CD4) and Viral load to confirm positive status. | Diagnostic test | HIV Without Insomnia, HIV and Insomnia |
Primary outcome
Pro-Inflammatory markers
Time frame: Baseline up to 8 weeks
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.
Anti-Inflammatory markers
Time frame: Baseline up to 8 weeks
IFN-a, TGF-B, IL4, IL-10 and IL-13 assays will be performed on the blood to identify levels of anti-inflammatory markers.
Oxidative Stress markers
Time frame: Baseline up to 8 weeks
Mitochondrial DNA damage, Damage associated molecular patterns (DAMPS) and Cortisolassays will be performed on the blood to identify levels of anti-inflammatory markers.
Pain threshold
Time frame: Baseline up to 1 week
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"
Pain tolerance
Time frame: Baseline up to 1 week
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.
Punctate Stimuli
Time frame: Baseline up to 1 week
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.
Temporal summation of pain
Time frame: Baseline up to 1 week
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.
Conditioned pain modulation
Time frame: Baseline up to 1 week
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.
Actigraph Sleep Measurement
Time frame: Baseline up to 8 weeks
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.
Weekly Sleep Diaries
Time frame: Baseline up to 8 weeks
A sleep diary including 15 daily questions will be filled out every day for seven days including questions about a participants nightly sleep experiences.
Weekly Caffeine Diaries
Time frame: Baseline up to 8 weeks
A caffeine dairy including different types of caffeine generally available for the participants to record their daily caffeine consumption of for seven days.
1 secondary outcome
Short Physical Performance Battery
Time frame: Week 2 up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 24795473Tenorio 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.
- Background: PubMed 28398572Goodin 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.
- Background: PubMed 28328552Merlin 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.
- Derived from this study: PubMed 41997468Webb CK, Gilstrap Wilson SR, Hobson JM, Stallworth HN, White-Gilliam DM, Owens MA, Cody SL, Justin Thomas S, Sorge RE, Goodin BR. Living with HIV and Insomnia: Implications for sleep quality, experimental pain sensitivity, and clinical pain severity. J Pain. 2026 Jul;44:106283. doi: 10.1016/j.jpain.2026.106283. Epub 2026 Apr 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burel R Goodin, PHd principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Insomnia, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pro-Inflammatory markers (time frame: Baseline up to 8 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04298658, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.