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The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and Tidal Volume is investigated during use of several products and comparing to baseline values
The study will be broken into one (1) arm:
• AffloVest® & Monarch™
Within the arm, the order of products will be randomized.
Baseline spirometry (Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Forced Expiratory Flow (FEF25-75%) and Tidal Volume (TV)) will be taken at the beginning, middle and end of each series of measurements with each subject, without any device on the subject. A product (AffloVest or Monarch) will be placed onto subject and turned ON to the highest frequency and intensity settings. Then the subject will be given a certain period of time to adjust and spirometry measurements will then be repeated, then the product will be removed and the subject will be allowed a recovery period, then the other product will be placed on the subject, turned ON and spirometry measurements will repeated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AffloVest Monarch Arm | Experimental | Devices placed on highest intensity / highest frequency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| International Biophysics AffloVest | Device | High-frequency chest wall oscillation vest |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices | Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques | 30 minutes |
| Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices | Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques | 30 minutes |
| Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices | Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques | 30 minutes |
| Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices | Forced Expiratory Volume in 1 second (FEV1) measures how much air a person can exhale during a forced breath during the first one (1) second, measured using standard spirometry techniques | 30 minutes |
| Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices | Forced Expiratory Flow (25-75%) is the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled, measured using standard spirometry techniques | 30 minutes |
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Inclusion Criteria:
- Healthy subject, ages 18 - 50
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas W O'Brien, MD | PDS Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PDS Research | Kissimmee | Florida | 34741 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AffloVest Monarch Arm | Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Hill-Rom Monarch: High-frequency chest wall oscillation vest |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AffloVest Monarch Arm | Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Hill-Rom Monarch: High-frequency chest wall oscillation vest |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices | Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques | Posted | Mean | Full Range | L | 30 minutes |
|
2 hours
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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 | Baseline | Patient baseline result | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Engineering and Quality | International Biophysics Corporation | 512-804-0046 | quality@biophysicscorp.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 | Jul 3, 2018 | Oct 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Hill-Rom Monarch | Device | High-frequency chest wall oscillation vest |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices | Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques | Posted | Mean | Full Range | L/s | 30 minutes |
|
|
|
| Primary | Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices | Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques | Posted | Mean | Full Range | L | 30 minutes |
|
|
|
| Primary | Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices | Forced Expiratory Volume in 1 second (FEV1) measures how much air a person can exhale during a forced breath during the first one (1) second, measured using standard spirometry techniques | Posted | Mean | Full Range | L | 30 minutes |
|
|
|
| Primary | Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices | Forced Expiratory Flow (25-75%) is the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled, measured using standard spirometry techniques | Posted | Mean | Full Range | L/s | 30 minutes |
|
|
|
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | AffloVest Arm | AffloVest placed on highest intensity | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Monarch Arm | Monarch placed on highest intensity | 0 | 10 | 0 | 10 | 0 | 10 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001982 | Bronchial Diseases |