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Dyspnea is the most common symptom limiting the ability of COPD patients to perform activities of daily living. Although there has been research involving the benefit of providing Non Invasive Ventilation (NIV) during exercise to increase tolerance overall, there is little research specifically looking at shortening dyspnea recovery times associated with exercise. We hypothesize that providing intermittent non-invasive positive pressure therapy (a form of NIV or PAP) with a handheld device to COPD patients immediately after exertion can relieve their dyspnea, and consequently allow them to be more active. In this study, we are comparing the distance walked as measured by a modified 6-Minute Walk Test (6MWT) of 20 COPD patients using VitaBreath (NIV) device versus Pursed Lip Breathing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitabreath Device | Experimental | The Philips Respironics investigational device VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support. Pressure support is defined as the difference between inhalation pressure and exhalation pressure. The study device is intended as an adjunct therapy to relieve shortness of breath in COPD patients who experience exertion-related dyspnea to allow them to be more active. The air is delivered to the patient via a mouthpiece on the device. |
|
| Pursed Lip Breathing | Active Comparator | Pursed lip breathing is a commonly used technique by COPD patients. That involves exhaling through tightly pressed lips and inhaling through the nose with the mouth closed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitabreath Device | Device | The VitaBreath device is designed for non-continuous use only and typical device use is expected to be for 2-3 minutes. The device should only be operated for less than 10 minutes at a time. After such time, the device should be turned off for at least 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Average Distance During Modified 6 Minute Walk Test | Compare the average distance walked during modified 6 minute walk test (M 6MWT) by COPD participants using Pursed Lip Breathing (PLB) versus an intermittent positive airway pressure handheld device, VitaBreath. | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pullmonary Rehabilition Associates | Youngstown | Ohio | 44512 | United States | ||
| Pittsburgh Pulmonary Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Screened | All participants that were consented. |
| FG001 | Vitabreath First, Pursed Lip Breathing Second | The Philips Respironics investigational device VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support. Pressure support is defined as the difference between inhalation pressure and exhalation pressure. The study device is intended as an adjunct therapy to relieve shortness of breath in COPD patients who experience exertion-related dyspnea to allow them to be more active. The air is delivered to the patient via a mouthpiece on the device. |
| FG002 | Pursed Lip Breathing First, Vitabreath Second | Pursed lip breathing is a commonly used technique by COPD patients. That involves exhaling through tightly pressed lips and inhaling through the nose with the mouth closed. Pursed Lip Breathing: Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
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| Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants that were consented. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Average Distance During Modified 6 Minute Walk Test | Compare the average distance walked during modified 6 minute walk test (M 6MWT) by COPD participants using Pursed Lip Breathing (PLB) versus an intermittent positive airway pressure handheld device, VitaBreath. | Posted | Mean | Standard Deviation | meters | 15 minutes |
|
1 Day
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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 | Participants Screened | All participants that were consented. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Biostatistician | Philips | 412-542-3651 | jeff.jasko@philips.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2017 | Mar 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Participants will receive two different interventions after exertion.
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|
| Pursed Lip Breathing | Other | Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator. |
|
| Jefferson Hills |
| Pennsylvania |
| 15025 |
| United States |
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMi) | One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan. | Mean | Standard Deviation | kg/m^2 |
|
| Heart Rate (bpm) | One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan | Mean | Standard Deviation | beats per minute |
|
| Systolic Blood Pressure (mmHg) | One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure (mmHg) | One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan | Mean | Standard Deviation | mmHg |
|
| FEV1(L) | One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan. | Mean | Standard Deviation | Liters |
|
| FEV1 (% Predicted) | One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan. | Mean | Standard Deviation | percentage of predicted FEV1 |
|
| FVC (L) | One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan. | Mean | Standard Deviation | Liters |
|
| FVC (% Predicted) | One participant screen failed due to the results of their CT scan, and is therefore missing the baseline data that would have been collected after the scan. | Mean | Standard Deviation | percentage of predicted FVC |
|
| Pack Years | Mean | Standard Deviation | packs per year |
|
| OG001 | Pursed Lip Breathing | Pursed lip breathing is a commonly used technique by COPD patients. That involves exhaling through tightly pressed lips and inhaling through the nose with the mouth closed. Pursed Lip Breathing: Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator. |
|
|
|
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Vitabreath First, Pursed Lip Breathing Second | VitaBreath is a handheld, battery powered, intermittent positive airway pressure device that is non-invasive, and provides positive airway pressure (PAP) of 18 cm water (H2O) during inspiration and 8 cm H2O on expiration, thus creating 10 cm H2O of pressure support will be utilized first, followed by standard of care Pursed Lip Breathing. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Pursed Lip Breathing First, Vitabreath Second | Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator first followed by use of Vitabreath | 0 | 10 | 0 | 10 | 0 | 10 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |