The Impact of Insomnia on Pain in HIV

Recruiting

• Conditions: HIV; Insomnia
• Interventions: 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; Diagnostic Test: Cluster of Differentiation 4 (CD4) and Viral load

• Registration Number: NCT04298658
• Lead Sponsor: University of Alabama at Birmingham

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-03-03
• Study First Posted: 2020-03-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-30
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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.
• Does not meets DSM-5 diagnostic criteria for insomnia including sleep difficulty.

Read More

Exclusion Criteria

• 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
• non-English speaking
• recent injury or surgical procedure within past 6 months.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV Without Insomnia	Quantitative Sensory testing (QST)	Participants will test positive for HIV and test negative for Insomnia.
Non HIV with Insomnia	Quantitative Sensory testing (QST)	Participants will test negative for HIV and test positive for Insomnia.
Non HIV with Insomnia	OraQuick Advance Rapid HIV 1/2 Swab test	Participants will test negative for HIV and test positive for Insomnia.
HIV Without Insomnia	Cluster of Differentiation 4 (CD4) and Viral load	Participants will test positive for HIV and test negative for Insomnia.
Non HIV with Insomnia	Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised	Participants will test negative for HIV and test positive for Insomnia.
Non HIV with Insomnia	Resmed ApneaLink Air device (Resmed, San Diego, CA).	Participants will test negative for HIV and test positive for Insomnia.
HIV and Insomnia	Resmed ApneaLink Air device (Resmed, San Diego, CA).	Participants will test positive for HIV and Insomnia.
HIV and Insomnia	Quantitative Sensory testing (QST)	Participants will test positive for HIV and Insomnia.
HIV and Insomnia	Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised	Participants will test positive for HIV and Insomnia.
HIV and Insomnia	Cluster of Differentiation 4 (CD4) and Viral load	Participants will test positive for HIV and Insomnia.
HIV Without Insomnia	Resmed ApneaLink Air device (Resmed, San Diego, CA).	Participants will test positive for HIV and test negative for Insomnia.
HIV Without Insomnia	Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised	Participants will test positive for HIV and test negative for Insomnia.
Non HIV Without Insomnia	Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised	Participants will test negative for HIV and test negative for Insomnia.
Non HIV Without Insomnia	Resmed ApneaLink Air device (Resmed, San Diego, CA).	Participants will test negative for HIV and test negative for Insomnia.
Non HIV Without Insomnia	OraQuick Advance Rapid HIV 1/2 Swab test	Participants will test negative for HIV and test negative for Insomnia.
Non HIV Without Insomnia	Quantitative Sensory testing (QST)	Participants will test negative for HIV and test negative for Insomnia.

Primary Outcome Measures

Name	Time	Method
Oxidative Stress markers	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.
Anti-Inflammatory markers	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.
Conditioned pain modulation	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.
Pain tolerance	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	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.
Pro-Inflammatory markers	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.
Pain threshold	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"
Actigraph Sleep Measurement	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	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.
Temporal summation of pain	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.
Weekly Caffeine Diaries	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.

Secondary Outcome Measures

Name	Time	Method
Short Physical Performance Battery	Week 2 up to 8 weeks	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).

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States