Heart Rate Variability Biofeedback: It's Role in Asthma Therapeutics
NCT02766374 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2019-01-15
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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