Short Sessions of HRV Biofeedback

July 14, 2023 updated by: Robert Hirten, Icahn School of Medicine at Mount Sinai

Remote Short Sessions of Heart Rate Variability Biofeedback

Remote 5 minute sessions of heart rate variability (HRV) biofeedback will be employed by participants for 5 weeks. Subjects will be followed for a total of 17 weeks. Surveys assessing psychological well being will be completed during the study period. Wearable devices will be worn to monitor HRV response during the study period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School Of Medicine At Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants were recruited from The Mount Sinai Hospital, Morningside Hospital, Mount Sinai West, Mount Sinai Beth Israel, Mount Sinai Queens, New York Eye and Ear Infirmary, and Mount Sinai Brooklyn.
  • Eligible participants were 18 years of age or greater.
  • Had an iPhone series 5 or greater.
  • Had or were willing to wear an Apple Watch 4 or greater.
  • Potential participants were excluded if they had an underlying chronic disease or used a medication that is known to impact autonomic nervous system function.

Exclusion Criteria:

  • Underlying chronic diseases including but not limited to:

    • rheumatoid arthritis
    • systemic lupus erythematosus
    • inflammatory bowel disease

  • Use of medications that impact heart rate variability including but not limited to:

    • beta-blockers (ie. atenolol, carvedilol, metoprolol, Coreg, Tenormin, Normodyne, Trandate)
    • digoxin
    • calcium channel blockers (ie. Norvasc, amlodipine, Cardene, nicardipine, Procardia, nifedipine, Cardizem, diltiazem)
    • regularly used benzodiazepines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRV Biofeedback
5 minute daily sessions of HRV biofeedback
Behavioral: HRV Biofeedback
5 minute daily sessions of HRV biofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: Up to Week 7
Heart rate variability measured in milliseconds (ms) at 7 weeks compared to baseline. Higher rates indicate increased parasympathetic nervous system activity.
Up to Week 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Connor-Davidson Resilience Scale (CD-RISC
Time Frame: Up to Week 17
Resilience: the Connor-Davidson Resilience scale (CD-RISC) quantifies stress coping ability. The CD-RISC is a 25-item self-administered scale. Scoring of the full 25 item scale is based on summing the total of each item, which is scored from 0-4. The full range is therefore from 0 to 100, with higher scores reflecting greater resilience.
Up to Week 17

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Robert Hirten, Icahn School Of Medicine At Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 14, 2023

First Posted (Estimated)

July 24, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY-21-00596

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Health care worker data is included in the dataset.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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