Heart Rate Variability Biofeedback: It's Role in Asthma Therapeutics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

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.
    

Detailed description: 
      The purpose of this study is to determine the role of Heart rate variability biofeedback
      (HRV-BF) in asthma management as either a controller (alternative) or bronchodilator
      (complementary) treatment, with respect to the current treatment of choice, inhaled
      corticosteroid (ICS) therapy, using different methods from participants that demonstrated
      clinically significant improvement in asthma outcomes in the investigator's previous research
      (1), and adding a second site not involved in the investigator's previous work.

      Inflammation of airways is viewed as the core pathophysiologic process in asthma. It is
      thought to render airways more reactive, and therefore, more susceptible to
      bronchoconstriction, leading to asthma exacerbations. Asthma is an episodic disease, where
      the goal of therapy is to reduce susceptibility to exacerbations, which may cause severe,
      even life-threatening illness. Anti-inflammatory medications reduce airways reactivity, while
      bronchodilator medications primarily relieve symptoms once an asthma exacerbation is in
      process, and may stop progressive constriction of airway smooth muscles (ASM). An
      anti-inflammatory effect of HRV-BF would have important implications for asthma management
      because adherence to ICS regimens is low due to a significant degree to feared side effects
      of prolonged steroid medication. Even if HRV-BF is found to only allow partial reduction in
      ICS requirements, this still would likely represent a major advance in asthma care.
    

Intervention name(s): Heart rate variability biofeedback; Placebo
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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).; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Asthma; Biofeedback; Heart rate variability biofeedback; Inhaled corticosteroids