Short Sessions of HRV Biofeedback

Resilience Clinical Trial

Official title:

Remote Short Sessions of Heart Rate Variability Biofeedback

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05958329
• Other study ID #: STUDY-21-00596
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: July 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Resilience

Intervention

Behavioral:
• HRV Biofeedback
5 minute daily sessions of HRV biofeedback

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability	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	Connor-Davidson Resilience Scale (CD-RISC	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