Heart Inflammation and Mental Stress Study

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Roger McIntosh，University of Miami

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

February 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^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.

Descriptive Information

Brief Title ^ICMJE

Heart Inflammation and Mental Stress Study

Official Title ^ICMJE

Heart Inflammation and Mental Stress Study

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Basic Science

Condition ^ICMJE

Intervention ^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

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

144

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

February 2023

Estimated Primary Completion Date

February 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

21 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Roger McIntosh，University of Miami

Study Sponsor ^ICMJE

University of Miami

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

University of Miami

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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