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The Impact of Insomnia on Pain 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.
Conditions:
🦠 HIV 🦠 Insomnia
🗓️ Study Start (Actual) 1 January 2020
🗓️ Primary Completion (Estimated) 31 July 2025
✅ Study Completion (Estimated) 31 July 2025
👥 Enrollment (Estimated) 240
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Birmingham, Alabama, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 20 February 2020
  • First Submitted that Met QC Criteria 3 March 2020
  • First Posted 6 March 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 July 2024
  • Last Update Posted 30 July 2024
  • Last Verified July 2024
I'm interested ...!!