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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 three (3) arms:
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 Compressor-based vest) 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 The Vest Arm | Experimental | Devices placed on highest intensity / highest frequency |
|
| AffloVest inCourage Arm | Experimental | Devices placed on highest intensity / highest frequency |
|
| AffloVest SmartVest 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 |
|---|---|---|
| TV | Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied | 30 minutes |
| PEF | Peak Expiratory Flow, a person's maximum speed of expiration | 30 minutes |
| FVC | Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible | 30 minutes |
| FEV1 | Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath | 30 minutes |
| FEF25-75% | Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC | 30 minutes |
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Inclusion Criteria:
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 The Vest Arm | Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Hill-Rom The Vest: High-frequency chest wall oscillation vest |
| FG001 | AffloVest inCourage Arm | Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Respirtech inCourage: High-frequency chest wall oscillation vest |
| FG002 | AffloVest SmartVest Arm | Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Electromed SmartVest: High-frequency chest wall oscillation vest |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AffloVest The Vest Arm | Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Hill-Rom The Vest: High-frequency chest wall oscillation vest |
| BG001 | AffloVest inCourage Arm |
| 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 | TV | Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied | Posted | Mean | Full Range | L | 30 minutes |
|
Study enrollment, approximately 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 | AffloVest The Vest Arm | Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Hill-Rom The Vest: High-frequency chest wall oscillation vest |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Engineering and Quality | International Biophysics Corporation | 512-814-0046 | quailty@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 | Apr 18, 2018 | Aug 6, 2018 | 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 The Vest | Device | High-frequency chest wall oscillation vest |
|
| Respirtech inCourage | Device | High-frequency chest wall oscillation vest |
|
| Electromed SmartVest | Device | High-frequency chest wall oscillation vest |
|
Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Respirtech inCourage: High-frequency chest wall oscillation vest |
| BG002 | AffloVest SmartVest Arm | Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Electromed SmartVest: High-frequency chest wall oscillation vest |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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 | Number | participants |
|
|
|
| Primary | PEF | Peak Expiratory Flow, a person's maximum speed of expiration | Posted | Mean | Full Range | L/s | 30 minutes |
|
|
|
| Primary | FVC | Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible | Posted | Mean | Full Range | L | 30 minutes |
|
|
|
| Primary | FEV1 | Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath | Posted | Mean | Full Range | L | 30 minutes |
|
|
|
| Primary | FEF25-75% | Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC | Posted | Mean | Full Range | L/s | 30 minutes |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | AffloVest inCourage Arm | Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Respirtech inCourage: High-frequency chest wall oscillation vest | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | AffloVest SmartVest Arm | Devices placed on highest intensity / highest frequency International Biophysics AffloVest: High-frequency chest wall oscillation vest Electromed SmartVest: High-frequency chest wall oscillation vest | 0 | 12 | 0 | 12 | 0 | 12 |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001982 | Bronchial Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|