The Impact of Insomnia on Pain in HIV (HIPPI)
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About
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.
Full 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.
Enrollment
Sex
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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.
Trial design
171 participants in 4 patient groups
Trial contacts and locations
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Central trial contact
Tammie L Quinn, B.A.; Dyan M White, B.S.
Data sourced from clinicaltrials.gov
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