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OpenTrials
Completed

NCT Number: NCT05958329

Short Sessions of HRV 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.

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Key information

Conditions

Resilience

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRV Biofeedback

Behavioral

5 minute daily sessions of HRV biofeedback

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Remote Short Sessions of Heart Rate Variability Biofeedback

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 24, 2023
Registry last updated
Jul 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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