Poor Sleep and Inflammation in HIV-Infected Adults

NCT03848325 | Completed Results

• 2 other identifiers: PRO17120573R01HL142118
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV-1-infection; Sleep Deprivation; Inflammation

Keywords

adenosine

Outcome Measures

Primary Outcomes (3)

• Soluble CD14

  Plasma concentration of soluble CD14

  Baseline sleep replete state and after 24 hours of sleep deprivation

• Soluble CD163

  Plasma concentration of soluble CD163

  Baseline sleep replete state and after 24 hours of sleep deprivation

• IL6

  Plasma concentration of interleukin-6

  Baseline sleep replete state and after 24 hours of sleep deprivation

Secondary Outcomes (5)

• Flow Mediated Brachial Artery Dilation

  Baseline sleep replete state and after 24 hours of sleep deprivation

• Monocyte Expression of IL6

  Baseline sleep replete state and after 24 hours of sleep deprivation

• Monocyte Expression of TNF-alpha

  Baseline sleep replete state and after 24 hours of sleep deprivation

• CD4+ T-cell Expression of HLA-DR and CD38

  Baseline sleep replete state and after 24 hours of sleep deprivation

• CD8+ T-cell Expression of HLA-DR and CD38

  Baseline sleep replete state and after 24 hours of sleep deprivation

Other Outcomes (5)

• Plasma Adenosine

  Baseline sleep replete state and after 24 hours of sleep deprivation

• Plasma Inosine

  Baseline sleep replete state and after 24 hours of sleep deprivation

• Urine 3'5'-cAMP

  Baseline sleep replete state and after 24 hours of sleep deprivation

Study Arms (1)

Sleep deprivation

EXPERIMENTAL

All subjects will be provided an 8 hour opportunity for sleep (Night 1) followed by outcome assessment the next morning (Day 1). They will then be kept awake the subsequent 24 hours including Night 2, followed by outcome assessment the following morning (Day 2).

Behavioral: Sleep deprivation

Interventions

Sleep deprivation BEHAVIORAL

Eight hour opportunity for sleep followed by 24 hours of sleep deprivation.

Sleep deprivation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Sleep Deprivation; Inflammation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Pathologic Processes

Results Point of Contact

• Title: Sanjay R. Patel MD, MS
• Organization: University of Pittsburgh

patelsr2@upmc.edu

412-383-0607

Study Officials

• Sanjay R Patel, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Bernard J Macatangay, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Technicians processing biospecimens will be blinded to whether samples were collected on Day 1 or Day 2. Similarly, the assessor of brachial artery reactivity measurements will be blinded to whether ultrasound images were collected on Day 1 or Day 2.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants will undergo one night of normal sleep (Night 1) followed by a subsequent night (Night 2) of sleep deprivation. Outcomes will be assessed the morning (Day 1 and Day 2) after each condition.

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 20, 2019
• Study Start: November 9, 2020
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: November 29, 2023
• Results First Posted: October 12, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)