N/A
N=20
Poor Sleep and Inflammation in HIV-Infected Adults
HIV-1-infection · Sleep Deprivation · Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT03848325 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Soluble CD14 — 1290; 1196 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep deprivation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Soluble CD14 |
1290; 1196 | — |
| PRIMARY Soluble CD163 |
359; 384 | — |
| PRIMARY IL6 |
4.46; 4.27 | — |
| SECONDARY Flow Mediated Brachial Artery Dilation |
6.13; 4.42 | — |
| SECONDARY Monocyte Expression of IL6 |
84.6; 89.1 | — |
| SECONDARY Monocyte Expression of TNF-alpha |
52.0; 64.1 | — |
| SECONDARY CD4+ T-cell Expression of HLA-DR and CD38 |
8.14; 8.39 | — |
| SECONDARY CD8+ T-cell Expression of HLA-DR and CD38 |
12.30; 13.17 | — |
Summary
People living with HIV (PLWH) often have poor sleep, which may put them at a higher risk for many chronic diseases, including cardiovascular disease. One of the mechanisms by which this may occur is via chronic inflammation and endothelial dysfunction. Adenosine plays an important role in sleep homeostasis, with levels increasing in the CSF in response to sleep deprivation and falling with sleep. Peripherally, adenosine, via its signaling pathway, plays an important role in immunoregulation by suppressing the inflammatory response. PLWH, even on antiretroviral therapy, have suppressed peripheral adenosine levels which are predictive of adverse cardiovascular outcomes. The hypothesis underlying this study is that acute sleep deprivation in PLWH does not result in a compensatory increase in extracellular adenosine and its signaling peripherally, and this failure to appropriately compensate, leads to an increase in systemic inflammation and endothelial dysfunction.
Eligibility Criteria
Inclusion Criteria
- HIV positive
- On continuous anti-retroviral therapy regimen for at least 48 weeks
- CD4+ cell count greater than or equal to 200 cells/mm^3
Exclusion Criteria
- Irregular or insufficient habitual sleep patterns
- Severe advanced or delayed sleep phase
- Primary sleep disorder
- Autoimmune disorder
- Use of immunosuppressant medications
- Use of medications impacting adenosine pathway
- Heavy caffeine use
- Active alcohol or drug abuse
- Elevated risk of adverse health effects from sleep deprivation (e.g., bipolar disorder, epilepsy, or suicidal ideation in the past 6 months)
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT03848325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.