Investigating how insomnia affects pain in people with HIV

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

This study is testing how insomnia affects pain and overall health in people living with HIV to see if better sleep can help manage their pain and inflammation.

Quick facts

• Study type: Observational
• Enrollment: 240 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (Academic / other)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT04298658 on ClinicalTrials.gov

What this trial studies

This study aims to explore the relationship between insomnia and pain, physical functioning, and inflammation in individuals living with HIV. It will assess whether insomnia increases sensitivity to pain and inflammatory responses, as well as how fluctuations in insomnia impact pain severity and physical health. Participants will undergo various assessments, including sleep evaluations and blood tests, to gather comprehensive data on their health status. The findings could establish insomnia as a target for therapeutic interventions in managing pain and inflammation in HIV patients.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with HIV who are experiencing insomnia and are receiving stable antiretroviral therapy.

Not a fit: Patients who do not have HIV or those with insomnia who are not receiving treatment at the UAB 1917 HIV Clinic may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved pain management strategies for patients living with HIV by addressing insomnia.

How similar studies have performed: While the specific relationship between insomnia and pain in HIV is less explored, similar studies have shown promising results in understanding the impact of sleep disorders on chronic pain conditions.

Eligibility criteria

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.

Where this trial is running

Birmingham, Alabama

• UAB — Birmingham, Alabama, United States (Recruiting)

Study contacts

• Principal investigator: Burel R Goodin, PHd — University of Alabama at Birmingham
• Study coordinator: Dyan M White, B.S.

Conditions HIV; Insomnia