N/A
N=88
HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction
HIV-1
Bottom Line
View on ClinicalTrials.gov: NCT04956861 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh) — 4.6; 4.2; 11.7; 9.9 mL/100 mL tissue/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Individualized Targeted Sleep (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Boulder
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Forearm Blood Flow (FBF) Response to Acetylcholine (ACh) |
4.6; 4.2; 11.7; 9.9; 12.4; 10.5 | — |
| PRIMARY Phase 2: FBF Response to Acetylcholine (ACh) |
4.2; 4.0; 9.2; 11.1; 9.9; 12.2 | — |
| PRIMARY Phase 1: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP) |
4.8; 4.0; 13.9; 12.4; 16.1; 14.5 | — |
| PRIMARY Phase 2: Forearm Blood Flow (FBF) Response to Sodium Nitroprusside (NTP) |
3.6; 4.2; 12.0; 13.8; 13.9; 14.6 | — |
| PRIMARY Phase 1: Endothelial Tissue Type Plasminogen Activator (t-PA) Release in Response to Bradykinin (BDK) |
-0.8; -1.0; 20.9; 11.4; 33.3; 23.8 | — |
| PRIMARY Phase 2: Endothelial t-PA Release in Response to Bradykinin (BDK) |
-1.8; -2.1; 15.1; 25.4; 20.6; 50.1 | — |
| PRIMARY Phase 1: FBF Response to ACh+Ng-monomethyl-L-arginine (L-NMMA) |
4.6; 4.0; 4.2; 3.3; 11.7; 9.2 | — |
| PRIMARY Phase 1: FBF Response to ACh+Vitamin C |
4.6; 5.1; 4.2; 4.4; 11.7; 14.3 | — |
| PRIMARY Phase 2: FBF Response to ACh+L-NMMA |
4.2; 3.3; 4.0; 3.8; 9.2; 9.0 | — |
| PRIMARY Phase 2: FBF Response to ACh+Vitamin C |
4.2; 4.3; 4.0; 4.8; 9.2; 12.6 | — |
| SECONDARY Nightly Sleep Duration |
7.8; 5.8 | — |
Summary
The investigators hypothesize that chronic insufficient sleep is associated with diminished endothelium-dependent nitric oxide-mediated vasodilation and tissue-type plasminogen activator release in anti-retroviral (ART)-treated HIV-1-seropositive adults. Furthermore, the investigators hypothesize that the postulated diminishment in endothelial vasodilator and fibrinolytic function with insufficient sleep will be due, at least in part, to increased oxidative stress. Moreover, increasing sleep duration and improving sleep quality will increase both endothelium-dependent nitric oxide-mediated vasodilation and endothelial tissue-type plasminogen activator release in ART-treated HIV-1-seropositive adults. Increases in endothelial vasodilator and fibrinolytic function will be due, at least in part, to reduced oxidative stress.
Eligibility Criteria
Inclusion Criteria
- Subjects will be men and women of all races and ethnic backgrounds aged 40-75 years with documented HIV-1 infection.
- Subjects will be HIV-1-seropositive individuals on a stable DHHS approved ART regimen for at least 6 months, with documented virologic suppression ( 200 cells/mm3 at the time of study entry.
- Subjects will be free of overt CVD as assessed by: a) medical history; b) physical examination; c) electrocardiogram and BP at rest and maximal exercise; d) complete blood chemistries, lipid and lipoprotein, glucose, insulin and hematological evaluation.
- All candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 6 months prior to the study.
Exclusion Criteria
- Receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
- Pre- or peri-menopausal women
Data sourced from ClinicalTrials.gov (NCT04956861). 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.