CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Heart Rate Variability Biofeedback Trainingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04589559
NCT04589559N/ACompleted

The Care After Life-threatening Medical Events (CALME) Pilot Study: An Investigation of Heart Rate Variability Biofeedback Training

Columbia University·interventional·Posted Oct 19, 2020·Updated Aug 19, 2022

In Brief

A clinical study evaluating Heart Rate Variability Biofeedback Training for Cardiac Arrest and Fear. Completed, enrolled 10 participants across 1 site.

Detailed Summary

This study tests the feasibility of a home-based heart rate variability biofeedback (HRVB) intervention in survivors of cardiac arrest (CA). Specifically, the primary purpose of this pilot study is to assess feasibility, acceptability, appropriateness, usability, and compliance for an at-home, 3-week HRVB intervention in 10 participants. The study also tests whether cardiac-related interoceptive fear, trait anxiety, and negative affect decrease among CA survivors completing the HRVB intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Arrest, Fear
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 19, 2020
Enrollment StartNov 23, 2020
Primary CompletionJul 23, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.7 years ago

Interventions

Heart Rate Variability Biofeedback Trainingbehavioral

First, participants are taught how to do relaxed, abdominal breathing. Second, they are taught how to breathe at a slow rate of 0.1 Hz (i.e., one completed breath cycle every 10 seconds). Third, they are taught how to monitor their heart rate variability (HRV) in real time using the smartphone app, which receives data wirelessly via Bluetooth from the heart rate monitor. Participants are instructed that their goal is to increase their HRV during the three weeks of at-home practice.