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

NCT02766374 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2019-01-15

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Heart rate variability biofeedback

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).

BEHAVIORAL

Placebo

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.

Sponsors & Collaborators

  • Rutgers University

    collaborator OTHER
  • National Jewish Health

    collaborator OTHER
  • National Institutes of Health (NIH)

    collaborator NIH
  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Fred Wamboldt, MD

    lead OTHER

Principal Investigators

  • Frederick S Wamboldt, MD · National Jewish Health

  • Paul Lehrer, PhD · Rutgers Robert Wood Johnson Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2015-10-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02766374 on ClinicalTrials.gov