Heart Inflammation and Mental Stress Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Heart Inflammation and Mental Stress Study

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Paced breathing
* Behavioral: Active relaxation


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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paced breathing<br>Individuals will be asked to sit in a quiet room while sensors collect their heart rate, respiratory rate and blood pressure for approximately 45 minutes. Individuals in this arm will engage in a paced breathing. Initial respiratory rate will be measured with a transducer. Participants will be connected to a paced breathing device (RESPERATE) that will gradually reduce the pace of audio tones presented to those individuals from spontaneous breathing rate down to 6 - 8 breaths per minute. | Behavioral: Paced breathing<br>* 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.<br>|
| Active Comparator: Relaxing music<br>Individuals will be asked to sit in a quiet room while sensors collect their heart rate, respiratory rate and blood pressure for approximately 45 minutes. Individuals will be provided with an audio device that plays soothing/relaxing music at a similar range (beats per minute) of the auditory signal presented during the experimental condition. Subjects will not be instructed how to breathe in this arm. | Behavioral: Active relaxation<br>* Individuals will be provided with headphones while resting quietly listening to relaxing tones/music.<br>|
| No Intervention: No intervention<br>Individuals will be asked to sit in a quiet room while sensors collect their heart rate, respiratory rate and blood pressure for approximately 45 minutes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High blood pressure, HIV