Heart Inflammation and Mental Stress Study

NCT03695146 | Completed DMC

• 2 other identifiers: 20180631K01HL139722-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

High blood pressure; HIV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in cytokine expression in peripheral blood mononuclear cells

  Baseline, pre-intervention and up to 60 minutes post-intervention

Study Arms (3)

Paced breathing

EXPERIMENTAL

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

Relaxing music

ACTIVE COMPARATOR

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

No intervention

NO INTERVENTION

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.

Interventions

Paced breathing BEHAVIORAL

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.

Paced breathing

Active relaxation BEHAVIORAL

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

Relaxing music

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pre-hypertension screening.
• HIV-antibody testing.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Roger C McIntosh, Ph.D.

  University of Miami, College of Arts and Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 3, 2018
• Study Start: August 19, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 22, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)