Status:
COMPLETED
The Impact of Insomnia on Pain in HIV
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
HIV
Insomnia
Eligibility:
All Genders
18-85 years
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)...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT04298658
Start Date
January 1 2020
End Date
July 31 2025
Last Update
September 17 2025
Active Locations (1)
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1
UAB
Birmingham, Alabama, United States, 35294