Heart Inflammation and Mental Stress Study

赞助:

合作者:

信息的提供 (责任方):

Roger McIntosh，University of Miami

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

November 2018

预计主要完成日期

February 2023 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Change in heart rate variability[ Time Frame: Baseline, pre-intervention and up to 60 minutes post-intervention ]

Heart rate variability will be measured using a standard electrocardiogram to detect variability in R -to-R intervals.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Change in cytokine expression in peripheral blood mononuclear cells[ Time Frame: Baseline, pre-intervention and up to 60 minutes post-intervention ]
Peripheral blood will be drawn and mononuclear cells isolated and incubated with lipopolysaccharide to induce inflammatory cytokine expression. The change in cytokine expression will be quantified as a function of time.

描述性信息

简略标题 ^ICMJE

Heart Inflammation and Mental Stress Study

正式标题 ^ICMJE

Heart Inflammation and Mental Stress Study

简要概况

The main objectives of the study are to assess (1) patterns of brain activity/connectivity that confers greater cardio-autonomic/emotion regulation, (e.g., heart rate variability, blood pressure reactivity, inflammatory-immune activation, etc.), during rest, mental stress, and anger-related distress, (2) whether changes in breathing pace mitigate task-based effects on cardio-autonomic-immune regulation, and (3) whether these patterns vary as a function of HIV or pre-hypertensive (HTN) status-related changes to the brain structures underlying cardioautonomic and emotion regulation.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Basic Science

适用条件 ^ICMJE

干预项目 ^ICMJE

Behavioral: Paced breathing
Individuals will be fitted with a respiratory transducer and receive auditory tones with which to pace their rate of inspiration and expiration in the experimental group.
Behavioral: Music relaxation
Individuals will be provided with headphones while resting quietly listening to soft music

研究工具

Experimental: Paced breathing
Active Comparator: Spontaneous breathing with music relaxation

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

144

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

February 2023

预计主要完成日期

February 2023 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion criteria: 1. pre-hypertension screening. 2. HIV-antibody testing. Exclusion criteria: 1. current use of anti-lipid, antihypertensive, or heart rate altering medications; 2. current or lifetime history of cardiovascular disease diagnosis or treatment including pulmonary stenosis, heart valve abnormalities and hypertension; 3. current or lifetime diagnoses of cancer, kidney/liver disease, hypertension, Type 1 or Type 2 diabetes; 4. history of trauma, cerebral infarction or hemorrhage; 5. current diagnosis and/or treatment for hypertension; 6. severe cognitive impairment; 7. current treatment or diagnosis of psychiatric illness; 8. metal implants or debris within the body; or pregnancy; 9. body mass index > 35; 10. use of hormone replacement therapy; and current smoker.

性别

参与研究的性别:

All

年龄

最小年龄：21 Years ，最大年龄：65 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Undecided

责任方

Roger McIntosh，University of Miami

研究赞助商 ^ICMJE

University of Miami

合作者 ^ICMJE

研究员 ^ICMJE

PRS 账户

University of Miami

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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