Trial Outcomes & Findings for Heart Rate Variability Biofeedback: It's Role in Asthma Therapeutics (NCT NCT02766374)
NCT ID: NCT02766374
Last Updated: 2019-01-15
Results Overview
Change in PEC20FEV1 measured after biofeedback from the PC20FEV1 measured at baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
4-weeks
Results posted on
2019-01-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
33
|
|
Overall Study
COMPLETED
|
25
|
30
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Heart Rate Variability Biofeedback: It's Role in Asthma Therapeutics
Baseline characteristics by cohort
| Measure |
HRV Biofeedback
n=35 Participants
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.
|
EEG+ Biofeedback
n=33 Participants
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.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38 years
n=99 Participants
|
31 years
n=107 Participants
|
34 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Reported use of Short Acting Beta Adrenergic Medication (SABA) > 3/week
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Asthma Control Test (ACT) score total
|
20 units on a scale
n=99 Participants
|
20 units on a scale
n=107 Participants
|
20 units on a scale
n=206 Participants
|
|
Percent of Asthma Control Test (ACT) score ≤ 19
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Baseline provocative conc causing 20% fall in forced expiratory volume in 1 sec (PC20FEV1) (mg/ml)
|
1.66 mg/ml
n=99 Participants
|
1.40 mg/ml
n=107 Participants
|
1.46 mg/ml
n=206 Participants
|
|
Forced Expiratory Volume in 1 sec (FEV1) (L)
|
2.79 Liters (L)
n=99 Participants
|
3.01 Liters (L)
n=107 Participants
|
2.89 Liters (L)
n=206 Participants
|
|
Precent predicted Forced Expiratory Volume in 1 sec (FEV1)
|
86.7 Percent
n=99 Participants
|
84.1 Percent
n=107 Participants
|
85.9 Percent
n=206 Participants
|
|
Forced Vital Capacity (FVC) (L)
|
3.78 Liters (L)
n=99 Participants
|
4.11 Liters (L)
n=107 Participants
|
4.04 Liters (L)
n=206 Participants
|
|
Precent predicted Forced Vital Capacity (FVC)
|
102.2 Percent
n=99 Participants
|
103.7 Percent
n=107 Participants
|
103.0 Percent
n=206 Participants
|
|
Peak Expiratory Flow Rate (PEFR) (L/s)
|
6.90 Liters/second (L/s)
n=99 Participants
|
7.66 Liters/second (L/s)
n=107 Participants
|
7.27 Liters/second (L/s)
n=206 Participants
|
|
Precent predicted Peak Expiratory Flow Rate (PEFR)
|
92.2 Percent
n=99 Participants
|
92.6 Percent
n=107 Participants
|
92.2 Percent
n=206 Participants
|
|
Exhaled Nitric Oxide cocentration (eNO) (ppb)
|
35.0 parts per billion (p/b)
n=99 Participants
|
43.0 parts per billion (p/b)
n=107 Participants
|
40.5 parts per billion (p/b)
n=206 Participants
|
|
Body Mass Index (BMI)
|
28.53 kg/m^2
n=99 Participants
|
27.41 kg/m^2
n=107 Participants
|
28.27 kg/m^2
n=206 Participants
|
PRIMARY outcome
Timeframe: 4-weeksChange in PEC20FEV1 measured after biofeedback from the PC20FEV1 measured at baseline
Outcome measures
| Measure |
HRV-BF
n=35 Participants
During the first training session, we will measure heart rate variability biofeedback 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.
|
PBO-BF
n=33 Participants
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.
|
|---|---|---|
|
Magnitude Change of Airway Reactivity Measured by Methacholine PC20FEV1
|
2.9782 mg/ml
Interval 1.393 to 6.3675
|
2.1181 mg/ml
Interval 1.2133 to 3.6977
|
Adverse Events
HRV Biofeedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EEG+ Biofeedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Paul M. Lehrer, PhD
Rutgers - Robert Wood Johnson Medical School
Phone: (732) 235-4413
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place