NCT03848325: SASH

Poor Sleep and Inflammation in HIV-Infected Adults

Completed NA Results posted Last updated 29 November 2023

What this trial tests

NA trial testing Sleep deprivation in HIV-1-infection in 20 participants. Completed in 31 July 2022.

Timeline

9 November 2020

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	9 November 2020
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Sleep deprivation

Conditions studied

• HIV-1-infection — all drugs for HIV-1-infection →
• Sleep Deprivation — all drugs for Sleep Deprivation →
• Inflammation — all drugs for Inflammation →

Sponsor

University of Pittsburgh

Who can join

Adults 18 to 75, any sex, with HIV-1-infection or Sleep Deprivation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Soluble CD14 Primary · Baseline sleep replete state and after 24 hours of sleep deprivation

Plasma concentration of soluble CD14

Baseline (Sleep repletion)

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	1290	± 405

After sleep deprivation

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	1196	± 533

Soluble CD163 Primary · Baseline sleep replete state and after 24 hours of sleep deprivation

Plasma concentration of soluble CD163

Baseline (Sleep repletion)

Group	Value	95% CI
Sleep Repletion Followed by Sleep Deprivation	359	± 231

After sleep deprivation

Group	Value	95% CI
Sleep Repletion Followed by Sleep Deprivation	384	± 250

IL6 Primary · Baseline sleep replete state and after 24 hours of sleep deprivation

Plasma concentration of interleukin-6

Baseline (Sleep repletion)

Group	Value	95% CI
Sleep Deprivation	4.46	± 2.06

After sleep deprivation

Group	Value	95% CI
Sleep Deprivation	4.27	± 1.14

Flow Mediated Brachial Artery Dilation Secondary · Baseline sleep replete state and after 24 hours of sleep deprivation

Percent change was calculated by measuring the brachial artery diameter at baseline and then the percent dilation from this baseline after release of occlusion at each time point.

Baseline (Sleep repletion)

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	6.13	± 2.68

After sleep deprivation

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	4.42	± 3.22

Monocyte Expression of IL6 Secondary · Baseline sleep replete state and after 24 hours of sleep deprivation

Percentage of circulating CD14+ peripheral blood mononuclear cells expressing interleukin-6

Baseline (Sleep repletion)

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	84.6	± 13.6

After sleep deprivation

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	89.1	± 8.3

Monocyte Expression of TNF-alpha Secondary · Baseline sleep replete state and after 24 hours of sleep deprivation

Percentage of circulating CD14+ peripheral blood mononuclear cells expressing tumor necrosis factor-alpha

Baseline (Sleep repletion)

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	52.0	± 37.4

After sleep deprivation

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	64.1	± 32.4

CD4+ T-cell Expression of HLA-DR and CD38 Secondary · Baseline sleep replete state and after 24 hours of sleep deprivation

Percentage of CD3+ CD4+ T-lymphocytes co-expressing HLA-DR and CD38

Baseline (Sleep repletion)

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	8.14	± 9.09

After sleep deprivation

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	8.39	± 9.01

CD8+ T-cell Expression of HLA-DR and CD38 Secondary · Baseline sleep replete state and after 24 hours of sleep deprivation

Percentage of CD3+ CD8+ T-lymphocytes co-expressing HLA-DR and CD38

Baseline (Sleep repletion)

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	12.30	± 10.74

After sleep deprivation

Group	Value	95% CI
Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation	13.17	± 11.06

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 hours. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Baseline (Sleep Repletion) Followed by Sleep Deprivation

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (1 terms — click to expand)

Reaction	System	Baseline (Sleep Repletion)…
Petechiae	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT03848325 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.