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Breathing Techniques for Heart Inflammation and Mental Stress (HIMS Trial)

N/A
Waitlist Available
Led By Roger C McIntosh, Ph.D.
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, pre-intervention and up to 60 minutes post-intervention
Awards & highlights

HIMS Trial Summary

This trial looks at how stress affects the cardiovascular system of people with and without HIV, and with or without hypertension.

Eligible Conditions
  • High Blood Pressure

HIMS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, pre-intervention and up to 60 minutes post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, pre-intervention and up to 60 minutes post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in heart rate variability
Secondary outcome measures
Change in cytokine expression in peripheral blood mononuclear cells

HIMS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Paced breathingExperimental Treatment1 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. 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.
Group II: No interventionActive Control1 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.
Group III: Relaxing musicActive Control1 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. 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paced breathing
2019
N/A
~150

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
899 Previous Clinical Trials
409,680 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,583 Total Patients Enrolled
Roger C McIntosh, Ph.D.Principal InvestigatorUniversity of Miami, College of Arts and Sciences

Media Library

Paced breathing Clinical Trial Eligibility Overview. Trial Name: NCT03695146 — N/A
High Blood Pressure Research Study Groups: No intervention, Paced breathing, Relaxing music
High Blood Pressure Clinical Trial 2023: Paced breathing Highlights & Side Effects. Trial Name: NCT03695146 — N/A
Paced breathing 2023 Treatment Timeline for Medical Study. Trial Name: NCT03695146 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are eligible to partake in this trial?

"Affirmative. The clinicaltrials.gov repository discloses that this research project, which was published on August 19th of 2019, is currently pursuing participants. This particular study requires 144 patients from 1 medical facility to be enrolled in the trial."

Answered by AI

Am I qualified to be a participant in this trial?

"The current clinical trial seeks 144 participants with hypertension and between the ages of 21 to 65."

Answered by AI

Are individuals under the age of 70 being considered as potential participants in this research?

"This study is enrolling volunteers aged 21 and up, with a maximum age of 65."

Answered by AI

Is enrollment still available for this clinical trial?

"Correct. Clinicaltrials.gov confirms that this clinical trial, posted on August 19th 2019 and amended September 27th 2022, is actively looking for participants with 144 patients being recruited at 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
University of Miami
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Heart Inflammation and Mental Stress Study
Roger McIntosh 2019. "Heart Inflammation and Mental Stress Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03695146.
~9 spots leftby Apr 2025
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