AsthmaBioAceNCT02766374
Heart Rate Variability Biofeedback: It's Role in Asthma Therapeutics
A study testing Heart rate variability biofeedback in people with Asthma, run by Fred Wamboldt, MD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Heart rate variability biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mild to moderate persistent asthma for at least the past one year
- Patients must not have taken oral or inhaled anti-inflammatory agents, including ICS and leukotriene inhibitors, for at least one month prior to study entry; and anti-IgE medications at least the past six months. Documented use of inhaled short-acting or long-acting β2-agonists during the month prior to study entry is, however, required. Xanthines, long-acting anticholinergics, and long-acting β2-agonists must be withdrawn within 72 hours upon entering the screening phase; short acting anticholinergics must be withdrawn within 48 hours before entering the screening phase. Patients will be required to abstain from these medications for the duration of study participation.
- FEV1 values must be ≥60% of predicted normal values following a 6 hour albuterol withhold, and reversibility of FEV1 of at least 12% (equal to or greater than 200 cc) following up to four puffs of albuterol must occur; or asthma physician at study site must state based on medical history, exam, and spirometry data that patient has presumptive mild-moderate persistent asthma.
- Lack of current asthma control as evidenced by ACT ≤ 19, or rescue use of B2-agonist ≥ 2/week within past 2 weeks, or waking due to asthma ≥ 1/week within past 2 weeks.
- Patients must be non-smokers for at least the past year and have less than a 15 pack-year smoking history. This will minimize the risk of co-occurring COPD
- Behavioral/linguistic competence: Ability to complete questionnaires and assessments in English
- Patients must give informed consent prior to any study procedures.
Who cannot join
- Diagnosis of severe persistent asthma
- 2 or more inpatient hospitalizations in the past year for asthma exacerbations;
- History of only seasonal asthma
- Patients with serious concomitant disease
- Patients who have had a respiratory tract infection within 4 weeks of screening
- Patients with a history of chronic bronchitis, COPD, or emphysema
Show all 16Show fewer
- Patients with a history of alcohol or drug abuse, or emotional or cognitive problems requiring psychotropic medication or likely to interfere procedural and treatment adherence
- Any other clinically relevant deviation from normal in general medical history, physical examination, or laboratory parameters that would limit participation or interfere with study procedures and/or data collection;
- Presence of exclusive extra-thoracic airway dysfunction
- Women who are pregnant
- Presence of a heart rhythm or other abnormality of heart rhythm on screening EKG that could preclude ac-curate HRV assessment
- Chronically taking any medication likely to affect the autonomic or respiratory systems
- Asthma therapy and concomitant medication
- Previous participation in an investigational drug trial within 30 days prior to screening.
- Concurrent participation in any other clinical trial or observational study at any time in the study.
- Planning to move away from the area within the next 4 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Jewish Health
Denver, Colorado, 80206
Rutgers Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854
About this study
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Heart rate variability biofeedback, Placebo
- Keywords
- Asthma, Biofeedback, Heart rate variability biofeedback, Inhaled corticosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variability biofeedbackBehavioural
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).
PlaceboBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Heart rate variability biofeedback |
| 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. Receives: Behavioral: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude Change of Airway Reactivity Measured by Methacholine PC20FEV1
Change in PEC20FEV1 measured after biofeedback from the PC20FEV1 measured at baseline
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startDec 2009
- Primary completionOct 2015
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Wamboldt, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers University, National Jewish Health, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Fred Wamboldt, MD, National Jewish Health
- Investigators
- Frederick S Wamboldt, MD, Principal investigator, National Jewish HealthPaul Lehrer, PhD, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766374
- Sponsor's protocol ID
- R01HL089495-01A2
- Other IDs
- R01HL089495-01A2
- Acronym
- BioAce
- Status last verified
- Jan 2019
- First submitted
- 14 Feb 2014
- Last updated
- 15 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 29124506
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability Biofeedback: It's Role in Asthma Therapeutics
- ClinicalTrials.gov ID
- NCT02766374
- Acronym / sponsor ID
- BioAce / R01HL089495-01A2
- Conditions
- Asthma
- Keywords
- Asthma, Biofeedback, Heart rate variability biofeedback, Inhaled corticosteroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Fred Wamboldt, MDUniversity, hospital or other
- Collaborators
- Rutgers University, National Jewish Health, National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2009
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 9 May 2016 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Rate Variability Biofeedback | Experimental | Behavioral: Heart rate variability biofeedbackDuring 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 | Behavioral: PlaceboA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Mild to moderate persistent asthma for at least the past one year
- Patients must not have taken oral or inhaled anti-inflammatory agents, including ICS and leukotriene inhibitors, for at least one month prior to study entry; and anti-IgE medications at least the past six months. Documented use of inhaled short-acting or long-acting β2-agonists during the month prior to study entry is, however, required. Xanthines, long-acting anticholinergics, and long-acting β2-agonists must be withdrawn within 72 hours upon entering the screening phase; short acting anticholinergics must be withdrawn within 48 hours before entering the screening phase. Patients will be required to abstain from these medications for the duration of study participation.
- FEV1 values must be ≥60% of predicted normal values following a 6 hour albuterol withhold, and reversibility of FEV1 of at least 12% (equal to or greater than 200 cc) following up to four puffs of albuterol must occur; or asthma physician at study site must state based on medical history, exam, and spirometry data that patient has presumptive mild-moderate persistent asthma.
- Lack of current asthma control as evidenced by ACT ≤ 19, or rescue use of B2-agonist ≥ 2/week within past 2 weeks, or waking due to asthma ≥ 1/week within past 2 weeks.
- Patients must be non-smokers for at least the past year and have less than a 15 pack-year smoking history. This will minimize the risk of co-occurring COPD
Key exclusion criteria (16 listed)
- Diagnosis of severe persistent asthma
- 2 or more inpatient hospitalizations in the past year for asthma exacerbations;
- History of only seasonal asthma
- Patients with serious concomitant disease
- Patients who have had a respiratory tract infection within 4 weeks of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate variability biofeedbackBiofeedback 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). | Behavioural | Heart Rate Variability Biofeedback |
| PlaceboThe 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. | Behavioural | Placebo Biofeedback |
Primary outcome
Magnitude Change of Airway Reactivity Measured by Methacholine PC20FEV1
Time frame: 4-weeks
Change in PEC20FEV1 measured after biofeedback from the PC20FEV1 measured at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29124506Lehrer 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick S Wamboldt, MD principal investigator
National Jewish Health
Paul Lehrer, PhD principal investigator
Rutgers Robert Wood Johnson Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate variability biofeedback in people with Asthma, run by Fred Wamboldt, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude Change of Airway Reactivity Measured by Methacholine PC20FEV1 (time frame: 4-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02766374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.