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NCT04298658Completed

The Impact of Insomnia on Pain in HIV

The Impact of Insomnia on Pain, Physical Function, and Inflammation in HIV

Source: ClinicalTrials.gov · Last updated 17 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
171 (actual)
First submitted
20 Feb 2020
Start date
1 Jan 2020
Primary completion date
31 Jul 2025
Lead sponsor
University of Alabama at Birmingham
Diseases
HIV
NCT number
NCT04298658

What you commit to

  • Study type: Observational
  • Participants enrolled: 171
  • From 1 Jan 2020 to the primary completion date, 31 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • concurrent medical conditions that could confound
  • recent injury or surgical procedure within past 6 months.

Other illness

  • 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
  • history of seizures
  • history of stroke or other neurological disorder
  • core body temperature \> 100 degrees Fahrenheit as this could indicate acute infection with fever; (k)

Other

  • interpretation of sleep
  • pain
  • asthma AND use of an inhaler
  • pregnancy
  • unwilling to provide blood for this study
  • non-English speaking

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UAB
Coordinator of this site? Confirm its status		BirminghamUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.