Clinical trial NCT04298658: The Impact of Insomnia on Pain in HIV
Official title: The Impact of Insomnia on Pain, Physical Function, and Inflammation in HIV
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
Insomnia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-03-06
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Pro-Inflammatory markers
timeFrame: Baseline up to 8 weeks
measure: Anti-Inflammatory markers
timeFrame: Baseline up to 8 weeks
measure: Oxidative Stress markers
timeFrame: Baseline up to 8 weeks
measure: Pain threshold
timeFrame: Baseline up to 1 week
measure: Pain tolerance
timeFrame: Baseline up to 1 week
measure: Punctate Stimuli
timeFrame: Baseline up to 1 week
measure: Temporal summation of pain
timeFrame: Baseline up to 1 week
measure: Conditioned pain modulation
timeFrame: Baseline up to 1 week
measure: Actigraph Sleep Measurement
timeFrame: Baseline up to 8 weeks
measure: Weekly Sleep Diaries
timeFrame: Baseline up to 8 weeks
measure: Weekly Caffeine Diaries
timeFrame: Baseline up to 8 weeks
Secondary outcomes:
measure: Short Physical Performance Battery
timeFrame: Week 2 up to 8 weeks
Other outcomes:
measure: Timed Up and Go (TUG) Task
timeFrame: Week 2 up to 8 weeks
measure: Munich Chrono Type Questionnaires (MCTQ)
timeFrame: Baseline
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline up to 8 weeks
measure: Demographics (DEMO)
timeFrame: Baseline
measure: Center for Epidemiological Studies - Depression (CESD)
timeFrame: Baseline up to 8 weeks
measure: RU Sated
timeFrame: Baseline up to 8 weeks
measure: Physical Health Questionnaire (PHQ-15)
timeFrame: Baseline
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline
measure: Dysfunctional Beliefs and Attitudes about Sleep (DBAAS)
timeFrame: Baseline
measure: Pain Interference and Intensity (PI-I)
timeFrame: week 1 up to 7 weeks
measure: Sorge 24 Hour Food Record
timeFrame: Baseline up to 1 week
measure: Sorge Dietary Habits
timeFrame: Baseline up to 1 week
measure: Drug Abuse Screening Test (DAST10)
timeFrame: Baseline up to 1 week
measure: State Trait Anxiety Inventory
timeFrame: Baseline up to 1 week
measure: Penn State Cigarette Dependence Index - Cigarettes
timeFrame: Baseline up to 1 week
measure: Penn State Cigarette Dependence Index - Ecigarettes
timeFrame: Baseline up to 1 week
measure: Alcohol Use Disorders Identification Test - C (AUDIT)
timeFrame: Baseline up to 1 week
measure: Alcohol Smoking and Substance Involvement Screening Test (ASSIST)
timeFrame: Baseline up to 1 week
measure: Anger PROMIS
timeFrame: Baseline up to 1 week
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline up to 1 week
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline up to 1 week
measure: HIV Stigma Mechanisms
timeFrame: Baseline up to 1 week
measure: Heightened Vigilance Scale (HVS)
timeFrame: Baseline up to 1 week
measure: Experience of Discrimination (EOD)
timeFrame: Baseline up to 1 week
measure: Adverse Childhood Experiences (ACE)
timeFrame: Baseline up to 1 week
measure: Lee Fatigue Scale (LFS)
timeFrame: Baseline up to 1 week
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Burel R Goodin, PHd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Goodin 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.
citation: Merlin 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.