COMPLETED

The Impact of Insomnia on Pain in HIV

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-01-01
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04298658

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed HIV diagnosis
  2. * currently a patient in the University of Alabama (UAB) 1917 HIV Clinic.
  3. * must be currently receiving stable antiretroviral therapy (ART).
  4. * Meets the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty.
  5. * Confirmed HIV diagnosis
  6. * currently a patient in the University of Alabama (UAB) 1917 HIV Clinic.
  7. * must be currently receiving stable antiretroviral therapy (ART).
  8. * Does not meet the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty.
  9. * Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic.
  10. * Meets DSM-5 diagnostic criteria for insomnia including sleep difficulty.
  11. * Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic.
  12. * Does not meets DSM-5 diagnostic criteria for insomnia including sleep difficulty.
  1. * concurrent medical conditions that could confound
  2. * interpretation of sleep
  3. * pain
  4. * inflammatory issues or coexisting diseases
  5. * Systemic rheumatic disease/condition
  6. * uncontrolled hypertension (i.e., BP \> 150/95)
  7. * circulatory disorders (e.g., Reynaud's disease)
  8. * history of heart disease or cardiac events
  9. * history of cancer
  10. * asthma AND use of an inhaler
  11. * history of seizures
  12. * history of stroke or other neurological disorder
  13. * pregnancy
  14. * core body temperature \> 100 degrees Fahrenheit as this could indicate acute infection with fever; (k)
  15. * unwilling to provide blood for this study
  16. * non-English speaking
  17. * recent injury or surgical procedure within past 6 months.

Contacts and Locations

Principal Investigator

Burel R Goodin, PHd
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

UAB
Birmingham, Alabama, 35294
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Burel R Goodin, PHd, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

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

Study Start Date2020-01-01
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2020-01-01
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • HIV
  • Insomnia