Short Sessions of HRV Biofeedback

NCT05958329 | Completed

• 1 other identifier: STUDY-21-00596
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Resilience

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Connor-Davidson Resilience Scale (CD-RISC

  Up to Week 17

Study Arms (1)

HRV Biofeedback

EXPERIMENTAL

5 minute daily sessions of HRV biofeedback

Behavioral: HRV Biofeedback

Interventions

HRV Biofeedback BEHAVIORAL

5 minute daily sessions of HRV biofeedback

HRV Biofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Study Officials

• Robert Hirten

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 24, 2023
• Study Start: July 1, 2021
• Primary Completion: July 15, 2022
• Study Completion: July 15, 2022
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)