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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04956861
Other study ID # 150465
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 17, 2015
Est. completion date August 7, 2020

Study information

Verified date June 2021
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date August 7, 2020
Est. primary completion date August 7, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Individualized Targeted Sleep
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.

Locations

Country Name City State
United States UC-Boulder Clinical and Translational Research Center Boulder Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase 1: Forearm blood flow (FBF) response to Acetylcholine (ACh) FBF response to ACh will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Primary Phase 2: FBF response to Acetylcholine (ACh) FBF to ACh will me measured following the participants 8 week sleep intervention FBF response to ACh will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Primary Phase 1: Forearm blood flow (FBF) response to Sodium Nitroprusside (NTP) FBF response to NTP will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Primary Phase 2: Forearm blood flow (FBF) response to Sodium Nitroprusside (NTP) FBF to NTP will me measured following the participants 8 week sleep intervention FBF response to NTP will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Primary Phase 1: Endothelial t-PA Release in response to Bradykinin (BDK) t-PA release will be measured during Phase 1 at the participants visit 3 which is ~3 weeks from their respective start date.
Primary 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 t-PA release will be measured during Phase 2 at the participants visit 9 which is ~11 weeks from their respective start date
Primary Phase 1: FBF response to ACh+L-NMMA 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.
Primary Phase 1: FBF response to ACh+Vitamin C 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.
Primary Phase 2: FBF response to ACh+L-NMMA FBF to ACh+L-NMMA will me measured following the participants 8 week sleep intervention 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
Primary Phase 2: FBF response to ACh+Vitamin C FBF to ACh+Vitamin C will me measured following the participants 8 week sleep intervention 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
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