HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction

University of Colorado Boulder (CU)

Status: Completed

Conditions: HIV-1

Treatments: Behavioral: Individualized Targeted Sleep

Study type: Interventional

Funder types: Other

Identifiers

NCT04956861

150465

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Phase 1

No Intervention group

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

Experimental group

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.

Treatment:

Behavioral: Individualized Targeted Sleep