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Short Sessions of HRV Biofeedback

Mount Sinai Health System logo

Mount Sinai Health System

Status

Completed

Conditions

Resilience

Treatments

Behavioral: HRV Biofeedback

Study type

Interventional

Funder types

Other

Identifiers

NCT05958329
STUDY-21-00596

Details and patient eligibility

About

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.

Enrollment

127 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

127 participants in 1 patient group

HRV Biofeedback
Experimental group
Description:
5 minute daily sessions of HRV biofeedback
Treatment:
Behavioral: HRV Biofeedback

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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