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| ID | Type | Description | Link |
|---|---|---|---|
| SMU IRB:KS08-051 | |||
| Baylor IRB: 001-180 | |||
| 5R01HL089761 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Baylor Health Care System | OTHER |
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For the proposed randomized controlled treatment study, the investigators plan to compare the effects of this hypoventilation-based breathing training with a control intervention that will focus on breathing regularity and awareness. The two therapeutic procedures are closely matched on important variables such as duration and the nature of patient-therapist interaction, monitoring asthma related status and the medication intake, use of scientific equipment and monitoring devices to increase adherence, and initial plausibility. Asthma patients who will be evaluated before, during, directly after, and at 2 months and 6 months after training.
For this randomized controlled treatment study, the investigators plan to compare the effects of hypoventilation-based breathing training with a control intervention that will focus on breathing regularity and awareness. The two therapeutic procedures are closely matched on important variables such as duration and the nature of patient-therapist interaction, monitoring asthma related status and the medication intake, use of scientific equipment and monitoring devices to increase adherence, and initial plausibility. Asthma patients will be evaluated before, during, directly after, and at 1 month and 6 months after training. The primary goal of this training is to determine if a capnometry-assisted breathing training to raise end-tidal CO2 will produce more improvement in asthma control than a control training of breathing awareness. The second goal is to determine if capnometry-assisted breathing training for raising pCO2 will lead to higher pCO2 levels after training than before training on all three measures of pCO2 (the 2-hour monitoring, the standardized training sessions, and the homework assignments). The last objective is to determine if the clinical improvement in asthma outcomes for the raise-pCO2 breathing group will be greater in patients with more improvement in their pCO2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breathing Training | Experimental | Patients will receive biofeedback assisted breathing training |
|
| Breathing Awareness | Active Comparator | Patients will receive biofeedback assisted breathing awareness training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capnometry Assisted Respiration Training | Behavioral | Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly, and shallowly in order to raise their PCO2 levels with the assistance of a biofeedback device. |
| Measure | Description | Time Frame |
|---|---|---|
| pCO2 levels (as an indicator of training manipulation success) | Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions, patients perform self-assessments on a daily basis throughout, pre- and post-treatment 2h monitoring | |
| diurnal PEF variability (as an indicator of asthma pathophysiology and control) | pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up | |
| Asthma Control Test (as a self-report indicator of asthma control) | Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up. Further assessments will be made at the beginning of each of the five weekly training sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| respiration rate from capnometry and further measures of ventilation from ambulatory recordings (as further indicators of training manipulation success) | Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions, patients perform self-assessments on a daily basis throughout, pre- and post-treatment 2h monitoring |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia Meuret, PhD | SMU | Principal Investigator |
| Thomas Ritz, PhD | SMU | Principal Investigator |
| Mark Millard, MD | BUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University Medical Center (BUMC) | Dallas | Texas | 75204 | United States | ||
| Southern Methodist University (SMU) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36961348 | Derived | Meuret AE, Rosenfield D, Millard MM, Ritz T. Biofeedback Training to Increase P co2 in Asthma With Elevated Anxiety: A One-Stop Treatment of Both Conditions? Psychosom Med. 2023 Jun 1;85(5):440-448. doi: 10.1097/PSY.0000000000001188. Epub 2023 Mar 23. | |
| 25122497 | Derived | Ritz T, Rosenfield D, Steele AM, Millard MW, Meuret AE. Controlling asthma by training of Capnometry-Assisted Hypoventilation (CATCH) vs slow breathing: a randomized controlled trial. Chest. 2014 Nov;146(5):1237-1247. doi: 10.1378/chest.14-0665. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004417 | Dyspnea |
| D012130 | Respiratory Hypersensitivity |
| D000402 | Airway Obstruction |
| D012135 | Respiratory Sounds |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Breathing Awareness | Behavioral | Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly using a biofeedback device. |
|
| FeNO | Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions |
| airway hyperreactivity by methacholine | at pretreatment and optionally at 1 month follow up |
| spirometric lung function and respiratory resistance (as further indicators of asthma pathophysiology) | Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions, patients perform self-assessments on a daily basis throughout. |
| reported symptoms | Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions, patients perform self-assessments on a daily basis throughout |
| monitored bronchodilator use | Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions, patients record usage throughout treatment |
| reported inhaled corticosteroid use (as self-report and behavioral indicators of asthma control) | Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions |
| effects on perceived general control of asthma management, asthma self-efficacy, and impact and control of asthma triggers (as an indicator of asthma self-management) | Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions |
| physical and mental health status, stress, anxiety and depression (as indicators of general well-being) | Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions |
| Dallas |
| Texas |
| 75275 |
| United States |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012131 | Respiratory Insufficiency |