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Short Sessions of HRV Biofeedback

Remote Short Sessions of Heart Rate Variability Biofeedback

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05958329
Enrollment
127
Registered
2023-07-24
Start date
2021-07-01
Completion date
2022-07-15
Last updated
2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resilience

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.

Interventions

BEHAVIORALHRV Biofeedback

5 minute daily sessions of HRV biofeedback

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate VariabilityUp to Week 7Heart rate variability measured in milliseconds (ms) at 7 weeks compared to baseline. Higher rates indicate increased parasympathetic nervous system activity.

Secondary

MeasureTime frameDescription
Connor-Davidson Resilience Scale (CD-RISCUp to Week 17Resilience: 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026