Short Sessions of HRV Biofeedback

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Completed
• CT.gov ID: NCT05958329
• Collaborator: (none)
• Enrollment: 127
• Location: 1
• Arm: 1
• Actual Duration (Months): 12.5
• Patients Per Site Per Month: 10.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Resilience	Behavioral: HRV Biofeedback	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 127 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Remote Short Sessions of Heart Rate Variability Biofeedback
• Actual Study Start Date: Jul 1, 2021
• Actual Primary Completion Date: Jul 15, 2022
• Actual Study Completion Date: Jul 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Heart Rate Variability [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.

Secondary Outcome Measures

1. Connor-Davidson Resilience Scale (CD-RISC [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Robert Hirten, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Hirten, Associate Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT05958329
• Other Study ID Numbers: STUDY-21-00596
• First Posted: Jul 24, 2023
• Last Update Posted: Jul 24, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 24, 2023