CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 68 enrolled
Drug / intervention
Heart rate variability biofeedback +1 morebehavioral
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/NCT02766374
NCT02766374N/ACompleted

Heart Rate Variability Biofeedback: It's Role in Asthma Therapeutics

Fred Wamboldt, MD·interventional·Posted May 9, 2016·Updated Jan 15, 2019

In Brief

A clinical study evaluating Heart rate variability biofeedback and Placebo for Asthma. Completed, enrolled 68 participants across 2 sites.

Detailed Summary

The goal of this research study to see whether biofeedback therapy helps treat asthma, and if so, how it works. Biofeedback is a treatment method that can teach how to bodily control. Biofeedback is widely used to help people relax. In this study however, the investigators want to learn if a specific type of biofeedback actually improves asthma in a way that might allow the reduction or elimination of other controller treatments like inhaled-corticosteroids.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2016
Enrollment StartDec 1, 2009
Primary CompletionOct 1, 2015
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 10.1 years ago

Interventions

Heart rate variability biofeedbackbehavioral

Biofeedback teaches voluntary control of physiological functions by providing instantaneous feedback of variations in that bodily activity. Feedback usually is given in the form of visual and/or auditory signals derived from physiological recording devices. Among its salutary effects is a sense of medical self-efficacy, i.e., less dependency on medical professionals for maintaining personal health. The HRV-BF protocol we have developed and propose to examine herein works by a different pathway. It involves teaching the individual to increase the amplitude of heart rate accelerations during inhalation and de-celerations during exhalation, thus increasing the amplitude of respiratory sinus arrhythmia (RSA).

Placebobehavioral

The method consists of: 1) receiving EEG/music biofeedback (actually, a mildly relaxing intervention, using EEG biofeedback to alternately increase and decrease frontal/occipital EEG alpha rhythms while listening to relaxing music), and 2) listening to recorded sounds of nature along with relaxing music with instructions to maintain a condition of "relaxed alertness." For home training, subjects will be given "placebo" StressEraser programmed to give feedback to maintain their breathing at baseline rate.