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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL089495-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Rutgers University | OTHER |
| National Jewish Health | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart Rate Variability Biofeedback | Experimental | During the first training session, we will measure heart rate variability (HRV) amplitude while the patient breathes for two minutes at a frequency ranging between 4.5-6.5 breaths/min, providing a "pacing stimulus" for this purpose. In subsequent sessions, the individual will be given personal heart rate variability biofeedback (HRV-BF), and instructed to increase the amplitude of heart rate oscillations, using a cardiotachometer tracing and frequency peaks as biofeedback stimuli, while avoiding hyperventilation symptoms, by breathing more shallowly, although slowly, at whatever frequency produces maximum-amplitude HRV. |
|
| Placebo Biofeedback | Placebo Comparator | A credible Placebo Biofeedback (PBO-BF) 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart rate variability biofeedback | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude Change of Airway Reactivity Measured by Methacholine PC20FEV1 | Change in PEC20FEV1 measured after biofeedback from the PC20FEV1 measured at baseline | 4-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick S Wamboldt, MD | National Jewish Health | Principal Investigator |
| Paul Lehrer, PhD | Rutgers Robert Wood Johnson Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| Rutgers Robert Wood Johnson Medical School |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29124506 | Result | Lehrer PM, Irvin CG, Lu SE, Scardella A, Roehmheld-Hamm B, Aviles-Velez M, Graves J, Vaschillo EG, Vaschillo B, Hoyte F, Nelson H, Wamboldt FS. Heart Rate Variability Biofeedback Does Not Substitute for Asthma Steroid Controller Medication. Appl Psychophysiol Biofeedback. 2018 Mar;43(1):57-73. doi: 10.1007/s10484-017-9382-0. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HRV Biofeedback | During the first training session, we will measure heart rate variability (HRV) amplitude while the patient breathes for two minutes at a frequency ranging between 4.5-6.5 breaths/min, providing a "pacing stimulus" for this purpose. In subsequent sessions, the individual will be given personal HRV biofeedback, and instructed to increase the amplitude of heart rate oscillations, using a cardiotachometer tracing and frequency peaks as biofeedback stimuli, while avoiding hyperventilation symptoms, by breathing more shallowly, although slowly, at whatever frequency produces maximum-amplitude HRV. This procedure detailed in Lehrer, P. M., Vaschillo, B., Zucker, T., Graves, J., Katsamanis, M.,Aviles, M., & Wamboldt, F. S. (2013). Protocol for heart rate variability biofeedback training. Biofeedback, 41(3), 98-109. |
| FG001 | EEG+ Biofeedback | Included instructions to increase and decrease EEG alpha from the right frontal to occipital areas (F4 to Oz), to listen regularly to relaxing music and to do paced breathing at the baseline rate of spontaneous breathing observed during a nondemanding task. Procedure detailed in Lehrer, P. M., Hochron, S. M., Mayne, T., Isenberg, S., Carlson, V., Lasoski, A. M., … Rausch, L. (1994). Relaxation and music therapies for asthma among patients prestabilized on asthma medication. Journal of Behavioral Medicine, 17(1), 1-24. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HRV Biofeedback | Biofeedback to maximaize heart rate variability. Procedure detailed in Lehrer, P. M., Vaschillo, B., Zucker, T., Graves, J., Katsamanis, M.,Aviles, M., & Wamboldt, F. S. (2013). Protocol for heart rate variability biofeedback training. Biofeedback, 41(3), 98-109. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Magnitude Change of Airway Reactivity Measured by Methacholine PC20FEV1 | Change in PEC20FEV1 measured after biofeedback from the PC20FEV1 measured at baseline | Posted | Mean | 95% Confidence Interval | mg/ml | 4-weeks |
|
4 week run-in, then 10 weeks of biofeedback.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HRV Biofeedback | Biofeedback to maximaize heart rate variability. Procedure detailed in Lehrer, P. M., Vaschillo, B., Zucker, T., Graves, J., Katsamanis, M.,Aviles, M., & Wamboldt, F. S. (2013). Protocol for heart rate variability biofeedback training. Biofeedback, 41(3), 98-109. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul M. Lehrer, PhD | Rutgers - Robert Wood Johnson Medical School | (732) 235-4413 | lehrer@rutgers.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| NIH |
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|
| Placebo | Behavioral | 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. |
|
| Piscataway |
| New Jersey |
| 08854 |
| United States |
| EEG+ Biofeedback |
Included instructions to increase and decrease EEG alpha from the right frontal to occipital areas (F4 to Oz), to listen regularly to relaxing music and to do paced breathing at the baseline rate of spontaneous breathing observed during a nondemanding task. Procedure detailed in Lehrer, P. M., Hochron, S. M., Mayne, T., Isenberg, S., Carlson, V., Lasoski, A. M., … Rausch, L. (1994). Relaxation and music therapies for asthma among patients prestabilized on asthma medication. Journal of Behavioral Medicine, 17(1), 1-24. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Reported use of Short Acting Beta Adrenergic Medication (SABA) > 3/week | SABA medication is used to treat asthma exacerbations, and using SABA > 3 times/week is taken as an indication of poorly controlled asthma. | Count of Participants | Participants |
|
| Asthma Control Test (ACT) score total | Range = 5-25 Scores > 19 indicate well-controlled asthma | Mean | Inter-Quartile Range | units on a scale |
|
| Percent of Asthma Control Test (ACT) score ≤ 19 | Range = 5-25 Scores > 19 indicate well-controlled asthma | Count of Participants | Participants |
|
| Baseline provocative conc causing 20% fall in forced expiratory volume in 1 sec (PC20FEV1) (mg/ml) | Score represents the dose of methacholine that results in a 20% fall in Forced Expiratory Volume in 1 sec (FEV1). Doses start at 0.31 mg/ml and doubling doses of methacholine up to 25 mg/ml are given with test stopped once a ≥ 20% fall in FEV1 is achieved, with the result reported being the interpolated concentration of methacholine that produced a 20% drop. If a 20% was not achieved with the highest dose of methacholine (i.e., 25 mg/ml) a score of 25 is assigned. Range = 0.31-25 mg/ml | Median | Inter-Quartile Range | mg/ml |
|
| Forced Expiratory Volume in 1 sec (FEV1) (L) | Quantity of air exhaled in the first second of a forced expiratory maneuver from maximum vital capacity measured using a spirometer. | Median | Inter-Quartile Range | Liters (L) |
|
| Precent predicted Forced Expiratory Volume in 1 sec (FEV1) | The percent predicted FEV1 is the FEV1 normalized as a percentage based on standards for an average healthy person of same age, race, height, and gender. | Median | Inter-Quartile Range | Percent |
|
| Forced Vital Capacity (FVC) (L) | Total air exhaled in a forced expiratory maneuver from maximum vital capacity measured using a spirometer. | Median | Inter-Quartile Range | Liters (L) |
|
| Precent predicted Forced Vital Capacity (FVC) | The percent predicted FVC is the FVC normalized as a percentage based on standards for an average healthy person of same age, race, height, and gender. | Median | Inter-Quartile Range | Percent |
|
| Peak Expiratory Flow Rate (PEFR) (L/s) | Peak expiratory flow rate during a forced airway maneuver from maximum vital capacity measured using a spirometer or a peak flow meter. | Median | Inter-Quartile Range | Liters/second (L/s) |
|
| Precent predicted Peak Expiratory Flow Rate (PEFR) | The percent predicted PEFR is the PEFR normalized as a percentage based on standards for an average healthy person of same age, race, height, and gender. | Median | Inter-Quartile Range | Percent |
|
| Exhaled Nitric Oxide cocentration (eNO) (ppb) | Exhaled concentration of nitric oxide in parts per billion (eNO). eNO greater than 50 ppb indicates that eosinophilic inflammation of the airways is likely to be present and, in symptomatic patients, responsiveness to corticosteroid medications is likely. | Median | Inter-Quartile Range | parts per billion (p/b) |
|
| Body Mass Index (BMI) | Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women. Scores = 25-29.9 indicate overweight status, Scores ≥ 30 indicate obese status | Median | Inter-Quartile Range | kg/m^2 |
|
| PBO-BF |
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. |
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|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | EEG+ Biofeedback | Included instructions to increase and decrease EEG alpha from the right frontal to occipital areas (F4 to Oz), to listen regularly to relaxing music and to do paced breathing at the baseline rate of spontaneous breathing observed during a nondemanding task. Procedure detailed in Lehrer, P. M., Hochron, S. M., Mayne, T., Isenberg, S., Carlson, V., Lasoski, A. M., … Rausch, L. (1994). Relaxation and music therapies for asthma among patients prestabilized on asthma medication. Journal of Behavioral Medicine, 17(1), 1-24. | 0 | 33 | 0 | 33 | 0 | 33 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |