NCT05958329CompletedNot Applicable
Remote Short Sessions of Heart Rate Variability Biofeedback
Icahn School of Medicine at Mount Sinai1 site in 1 country127 target enrollmentStarted: July 1, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 127
- Locations
- 1
- Primary Endpoint
- Heart Rate Variability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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)
- •calcium channel blockers (ie. Norvasc, amlodipine, Cardene, nicardipine, Procardia, nifedipine, Cardizem, diltiazem)
- •regularly used benzodiazepines
Arms & Interventions
HRV Biofeedback
Experimental
5 minute daily sessions of HRV biofeedback
Intervention: HRV Biofeedback (Behavioral)
Outcomes
Primary Outcomes
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
- Connor-Davidson Resilience Scale (CD-RISC(Up to Week 17)
Investigators
Robert Hirten
Associate Professor
Icahn School of Medicine at Mount Sinai
Study Sites (1)
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