Trial Outcomes & Findings for Poor Sleep and Inflammation in HIV-Infected Adults (NCT NCT03848325)

NCT ID: NCT03848325

Last Updated: 2023-11-29

Results Overview

Plasma concentration of soluble CD14

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation
• Results posted on: 2023-11-29

Participant Flow

Participant milestones

Measure	Sleep Repletion Followed by Sleep Deprivation An 8 hour opportunity for sleep followed by outcome assessment the next morning and then 24 hour sleep deprivation followed by repeat outcome assessment.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Poor Sleep and Inflammation in HIV-Infected Adults

Baseline characteristics by cohort

Measure	Baseline (Sleep Repletion) Followed by Sleep Deprivation n=20 Participants An 8 hour opportunity for sleep followed by outcome assessment the next morning and then 24 hour sleep deprivation followed by repeat outcome assessment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	61.1 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

Plasma concentration of soluble CD14

Outcome measures

Measure	Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation n=20 Participants An 8 hour opportunity for sleep followed by outcome assessment the next morning and then 24 hour sleep deprivation followed by repeat outcome assessment.
Soluble CD14 Baseline (Sleep repletion)	1290 ng/mL Standard Deviation 405
Soluble CD14 After sleep deprivation	1196 ng/mL Standard Deviation 533

PRIMARY outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

Population: All 20 participants who completed the protocol and whose blood sample met quality control for the assay performed.

Plasma concentration of soluble CD163

Outcome measures

Measure	Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation n=20 Participants An 8 hour opportunity for sleep followed by outcome assessment the next morning and then 24 hour sleep deprivation followed by repeat outcome assessment.
Soluble CD163 Baseline (Sleep repletion)	359 ng/mL Standard Deviation 231
Soluble CD163 After sleep deprivation	384 ng/mL Standard Deviation 250

PRIMARY outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

Population: All 20 participants who completed the protocol and whose blood sample met quality control for the assay performed.

Plasma concentration of interleukin-6

Outcome measures

Measure	Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation n=20 Participants An 8 hour opportunity for sleep followed by outcome assessment the next morning and then 24 hour sleep deprivation followed by repeat outcome assessment.
IL6 Baseline (Sleep repletion)	4.46 pg/mL Standard Deviation 2.06
IL6 After sleep deprivation	4.27 pg/mL Standard Deviation 1.14

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation n=20 Participants An 8 hour opportunity for sleep followed by outcome assessment the next morning and then 24 hour sleep deprivation followed by repeat outcome assessment.
Flow Mediated Brachial Artery Dilation Baseline (Sleep repletion)	6.13 % change Standard Deviation 2.68
Flow Mediated Brachial Artery Dilation After sleep deprivation	4.42 % change Standard Deviation 3.22

SECONDARY outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

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

Outcome measures

Measure	Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation n=20 Participants An 8 hour opportunity for sleep followed by outcome assessment the next morning and then 24 hour sleep deprivation followed by repeat outcome assessment.
Monocyte Expression of IL6 Baseline (Sleep repletion)	84.6 % cells Standard Deviation 13.6
Monocyte Expression of IL6 After sleep deprivation	89.1 % cells Standard Deviation 8.3

SECONDARY outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

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

Outcome measures

Measure	Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation n=20 Participants An 8 hour opportunity for sleep followed by outcome assessment the next morning and then 24 hour sleep deprivation followed by repeat outcome assessment.
Monocyte Expression of TNF-alpha Baseline (Sleep repletion)	52.0 % cells Standard Deviation 37.4
Monocyte Expression of TNF-alpha After sleep deprivation	64.1 % cells Standard Deviation 32.4

SECONDARY outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

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

Outcome measures

Measure	Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation n=20 Participants An 8 hour opportunity for sleep followed by outcome assessment the next morning and then 24 hour sleep deprivation followed by repeat outcome assessment.
CD4+ T-cell Expression of HLA-DR and CD38 Baseline (Sleep repletion)	8.14 % cells Standard Deviation 9.09
CD4+ T-cell Expression of HLA-DR and CD38 After sleep deprivation	8.39 % cells Standard Deviation 9.01

SECONDARY outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

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

Outcome measures

Measure	Baseline (Sleep Replete State) Followed by 24 Hours of Sleep Deprivation n=20 Participants An 8 hour opportunity for sleep followed by outcome assessment the next morning and then 24 hour sleep deprivation followed by repeat outcome assessment.
CD8+ T-cell Expression of HLA-DR and CD38 Baseline (Sleep repletion)	12.30 % cells Standard Deviation 10.74
CD8+ T-cell Expression of HLA-DR and CD38 After sleep deprivation	13.17 % cells Standard Deviation 11.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

Plasma adenosine concentration

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

Plasma inosine concentration

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

Urine 3'5'-cyclic adenosine monophosphate concentration normalized to creatinine

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

Percentage of CD3+ CD4+ T-lymphocytes expressing CD39 and/or CD73

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline sleep replete state and after 24 hours of sleep deprivation

Percentage of CD3+ CD8+ T-lymphocytes expressing CD39 and/or CD73

Outcome measures

Outcome data not reported

Adverse Events

Baseline (Sleep Repletion) Followed by Sleep Deprivation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Baseline (Sleep Repletion) Followed by Sleep Deprivation n=20 participants at risk An 8 hour opportunity for sleep followed by outcome assessment the next morning and then 24 hour sleep deprivation followed by repeat outcome assessment.
Skin and subcutaneous tissue disorders Petechiae	5.0% 1/20 • Number of events 1 • 24 hours

Additional Information

Sanjay R. Patel MD, MS

University of Pittsburgh

Phone: 412-383-0607

Email: patelsr2@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place