Short Sessions of HRV Biofeedback

Not Applicable

Completed

• Conditions: Resilience
• Interventions: Behavioral: HRV Biofeedback

• Registration Number: NCT05958329
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-15
• Status Verified: 2023-07
• Study First Submitted: 2023-07-14
• Study First Submitted QC: 2023-07-14
• Last Update Submitted: 2023-07-14
• Study First Posted: 2023-07-24
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HRV Biofeedback	HRV Biofeedback	5 minute daily sessions of HRV biofeedback

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States