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It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized Crossover to ElectroFlo | Experimental | Experimental: ElectroFlo 5000, then VEST Patients are randomized to a sequence of ElectroFlo 5000 on one visit and during the second visit, they cross-over to the Vest system. |
|
| Randomized Crossover to Vest | Experimental | Experimental: VEST, then ElectroFlo 5000 Patients are randomized to a sequence of Vest system on one visit and during the second visit, they cross-over to the ElectroFlo 5000. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro Flo 5000 | Device | Airway clearance device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wet Sputum Weight | Sputum was collected in pre-measured cups in a blinded fashion | End of study visit per intervention |
| Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST. | Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive. | End of study visit per intervention |
| Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest. | Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive. | End of study visit per intervention |
| Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest | Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable) | End of study visit per intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Dry Sputum Weight | Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry | End of study visit per intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Vest First Then ElectroFlo | Experimental: VEST, then ElectroFlo 5000 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of Vest at one visit and during the second visit, they crossed-over to the ElectroFlo 5000. EnCourage Vest System: Airway Clearance Device |
| FG001 | ElectroFlo First Then Vest | Experimental: ElectroFlo 5000, then VEST 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of ElectroFlo 5000 at one visit and during the second visit, they crossed-over to the Vest. Electro Flo 5000: Airway clearance device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Number of Participants |
| 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 | Wet Sputum Weight | Sputum was collected in pre-measured cups in a blinded fashion | Posted | Mean | Full Range | grams | End of study visit per intervention |
|
|
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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 | Vest Arm | Vest arm Incourage Vest System: Airway Clearance Device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos Milla, MD | Stanford University | 650-723-5193 | cmilla@stanford.edu |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Incourage Vest System |
| Device |
Airway Clearance Device |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Dry Sputum Weight | Sputum was collected in pre-measured cups in a blinded fashion, dessicated and measured dry | Posted | Mean | Full Range | gram | End of study visit per intervention |
|
|
|
| Primary | Pulmonary Function Measured as a Percent Predicted BEFORE Therapy With Either ElectroFlo 5000 / VEST. | Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive. | Posted | Mean | Full Range | percentage of predicted value | End of study visit per intervention |
|
|
|
| Primary | Pulmonary Function Measured as a Percent Predicted AFTER Therapy With Either ElectroFlo 5000 / Vest. | Comparison of pulmonary function by doing spirometry testing on study patients during their Day 1 & Day 2 therapy sessions. Will also compare the results based on the therapies they receive. | Posted | Mean | Full Range | percentage of predicted value | End of study visit per intervention |
|
|
|
| Primary | Comfort Level After Receiving Therapy With Either ElectroFlo 5000 / Vest | Comfort assessed on a scale of 1-10 by patients after therapy after each visit (1 being most comfortable, 10 being most un-comfortable) | Posted | Mean | Full Range | units on a scale | End of study visit per intervention |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | ElectroFlo Arm | ElectroFlo Arm Electro Flo 5000: Airway clearance device | 0 | 15 | 0 | 15 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |