Heart Inflammation and Mental Stress Study

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Paced breathing; Behavioral: Active relaxation

• Registration Number: NCT03695146
• Lead Sponsor: University of Miami

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• Study Start: 2019-08-19
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paced breathing	Paced breathing	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.
Relaxing music	Active relaxation	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.

Primary Outcome Measures

Name	Time	Method
Change in heart rate variability	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.

Secondary Outcome Measures

Name	Time	Method
Change in cytokine expression in peripheral blood mononuclear cells	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States