Back to resultsHIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction
Primary Purpose
HIV-1
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individualized Targeted Sleep
Sponsored by
About this trial
This is an interventional basic science trial for HIV-1 focused on measuring Sleep
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 (<50 copies HIV-1 RNA/mL) for at least 3 months.
- All subjects must have CD4+ T cell counts >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 preceeding 3-year period.
- Pre- or peri-menopausal women
Sites / Locations
- UC-Boulder Clinical and Translational Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Phase 1
Phase 2
Arm Description
Phase 1 is a cross-sectional study to compare endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 7 hours/night (short sleep).
Phase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night.
Outcomes
Primary Outcome Measures
Phase 1: Forearm blood flow (FBF) response to Acetylcholine (ACh)
Phase 2: FBF response to Acetylcholine (ACh)
FBF to ACh will me measured following the participants 8 week sleep intervention
Phase 1: Forearm blood flow (FBF) response to Sodium Nitroprusside (NTP)
Phase 2: Forearm blood flow (FBF) response to Sodium Nitroprusside (NTP)
FBF to NTP will me measured following the participants 8 week sleep intervention
Phase 1: Endothelial t-PA Release in response to Bradykinin (BDK)
Phase 2: Endothelial t-PA Release in response to Bradykinin (BDK)
Endothelial t-PA release will me measured following the participants 8 week sleep intervention
Phase 1: FBF response to ACh+L-NMMA
Phase 1: FBF response to ACh+Vitamin C
Phase 2: FBF response to ACh+L-NMMA
FBF to ACh+L-NMMA will me measured following the participants 8 week sleep intervention
Phase 2: FBF response to ACh+Vitamin C
FBF to ACh+Vitamin C will me measured following the participants 8 week sleep intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT04956861
First Posted
June 23, 2021
Last Updated
June 30, 2021
Sponsor
University of Colorado, Boulder
1. Study Identification
Unique Protocol Identification Number
NCT04956861
Brief Title
HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction
Official Title
HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 17, 2015 (Actual)
Primary Completion Date
August 7, 2020 (Actual)
Study Completion Date
August 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Boulder
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV-1
Keywords
Sleep
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1
Arm Type
No Intervention
Arm Description
Phase 1 is a cross-sectional study to compare endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep more than 7 hours/night (normal sleep) and those who habitually sleep less than 7 hours/night (short sleep).
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
Phase 2 is an intervention study to determine the effects of individualized targeted sleep interventions that increase sleep duration and improve sleep quality on endothelial vasodilator and fibrinolytic function in ART-treated HIV-1-seropositive adults who habitually sleep less than 7 hours/night.
Intervention Type
Behavioral
Intervention Name(s)
Individualized Targeted Sleep
Intervention Description
The investigators will employ an 8-week individualized targeted sleep intervention. Individualized targeted interventions have the advantage of improving adherence, reducing attrition, and making the strategy personally meaningful.
Primary Outcome Measure Information:
Title
Phase 1: Forearm blood flow (FBF) response to Acetylcholine (ACh)
Time Frame
FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Title
Phase 2: FBF response to Acetylcholine (ACh)
Description
FBF to ACh will me measured following the participants 8 week sleep intervention
Time Frame
FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Title
Phase 1: Forearm blood flow (FBF) response to Sodium Nitroprusside (NTP)
Time Frame
FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Title
Phase 2: Forearm blood flow (FBF) response to Sodium Nitroprusside (NTP)
Description
FBF to NTP will me measured following the participants 8 week sleep intervention
Time Frame
FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Title
Phase 1: Endothelial t-PA Release in response to Bradykinin (BDK)
Time Frame
t-PA release will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Title
Phase 2: Endothelial t-PA Release in response to Bradykinin (BDK)
Description
Endothelial t-PA release will me measured following the participants 8 week sleep intervention
Time Frame
t-PA release will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Title
Phase 1: FBF response to ACh+L-NMMA
Time Frame
FBF response to ACh+L-NMMA will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Title
Phase 1: FBF response to ACh+Vitamin C
Time Frame
FBF response to ACh+Vitamin C will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Title
Phase 2: FBF response to ACh+L-NMMA
Description
FBF to ACh+L-NMMA will me measured following the participants 8 week sleep intervention
Time Frame
FBF response to ACh+L-NMMA will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Title
Phase 2: FBF response to ACh+Vitamin C
Description
FBF to ACh+Vitamin C will me measured following the participants 8 week sleep intervention
Time Frame
FBF response to ACh+Vitamin C will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 (<50 copies HIV-1 RNA/mL) for at least 3 months.
All subjects must have CD4+ T cell counts >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 preceeding 3-year period.
Pre- or peri-menopausal women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher DeSouza, PhD
Organizational Affiliation
University of Colorado, Boulder
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC-Boulder Clinical and Translational Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States
12. IPD Sharing Statement
Learn more about this trial
HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction
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