HIV-1, Insufficient Sleep and Vascular Endothelial Dysfunction

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-17

Study Completion Date

2020-08-07

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV-1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Phase 1

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Phase 2

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.

Group Type EXPERIMENTAL

Individualized Targeted Sleep

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.