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Heart Inflammation and Mental Stress Study (HIMS)

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paced breathing
Active relaxation
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypertension focused on measuring High blood pressure, HIV

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Paced breathing

Relaxing music

No intervention

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in heart rate variability
Heart rate variability will be measured using a standard electrocardiogram to detect variability in R -to-R intervals.

Secondary Outcome Measures

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.

Full Information

First Posted
September 28, 2018
Last Updated
October 18, 2023
Sponsor
University of Miami
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03695146
Brief Title
Heart Inflammation and Mental Stress Study
Acronym
HIMS
Official Title
Heart Inflammation and Mental Stress Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
High blood pressure, HIV

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paced breathing
Arm Type
Experimental
Arm Description
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.
Arm Title
Relaxing music
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Paced breathing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Active relaxation
Intervention Description
Individuals will be provided with headphones while resting quietly listening to relaxing tones/music.
Primary Outcome Measure Information:
Title
Change in heart rate variability
Description
Heart rate variability will be measured using a standard electrocardiogram to detect variability in R -to-R intervals.
Time Frame
Baseline, pre-intervention and up to 60 minutes post-intervention
Secondary Outcome Measure Information:
Title
Change in cytokine expression in peripheral blood mononuclear cells
Description
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.
Time Frame
Baseline, pre-intervention and up to 60 minutes post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roger C McIntosh, Ph.D.
Phone
305-243-2047
Email
r.mcintosh@miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Dillon, M.S.
Phone
305-243-1266
Email
kxd@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger C McIntosh, Ph.D.
Organizational Affiliation
University of Miami, College of Arts and Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger C McIntosh, PhD
Phone
305-243-2047
Ext
3
Email
r.mcintosh@miami.edu
First Name & Middle Initial & Last Name & Degree
Roger C McIntosh, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Heart Inflammation and Mental Stress Study

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