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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03695146
Other study ID # 20180631
Secondary ID K01HL139722-01
Status Completed
Phase N/A
First received
Last updated
Start date August 19, 2019
Est. completion date December 22, 2023

Study information

Verified date February 2024
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate the neural underpinnings of cardiovascular reactivity to mental stress as a function of HIV and hypertensive risk.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 22, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
Active relaxation
Individuals will be provided with headphones while resting quietly listening to relaxing tones/music.

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in heart rate variability Heart rate variability will be measured using a standard electrocardiogram to detect variability in R -to-R intervals. Baseline, pre-intervention and up to 60 minutes post-intervention
Secondary Change in cytokine expression in peripheral blood mononuclear cells 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. Baseline, pre-intervention and up to 60 minutes post-intervention
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