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CompletedNCT05958329Updated Jul 24, 2023

Short Sessions of HRV Biofeedback

An interventional study of HRV Biofeedback in Resilience, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years after the study started (first participant enrolled Jul 2021, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Resilience
03

In context

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    HRV Biofeedback

    5 minute daily sessions of HRV biofeedback

    Behavioral: HRV Biofeedback

Interventions

  • BehavioralHRV Biofeedback

    5 minute daily sessions of HRV biofeedback

06

What researchers measure

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.

    Time frame: Up to Week 7

Secondary outcomes

  1. 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.

    Time frame: Up to Week 17

07

Study locations

1 site
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
08

References and documents

Individual participant data

Plan to share: No — Health care worker data is included in the dataset.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05958329
Lead sponsor
Icahn School of Medicine at Mount Sinai
Responsible party
Robert Hirten (Associate Professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Jul 24, 2023
Start date
Jul 1, 2021
Primary completion
Jul 15, 2022
Completion
Jul 15, 2022
Last update
Jul 24, 2023

Study contacts

Robert Hirten
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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