Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

Study Overview
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Brief Summary
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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.

Detailed Description
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The study will be broken into three (3) arms: AffloVest® & The Vest® AffloVest® & inCourage® AffloVest® & SmartVest® Subjects will be randomly assigned to an arm. Within each arm, the order of products will be also 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 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.

Official Title
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Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

Conditions
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Cystic Fibrosis, Bronchiectasis

Intervention / Treatment
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* Device: International Biophysics AffloVest
* Device: Hill-Rom The Vest
* Device: Respirtech inCourage
* Device: Electromed SmartVest


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subject, ages 18 - 50 Exclusion Criteria: Non-ambulatory, diagnosed neuromuscular disorder, currently using any type of oscillation vest therapy, diagnosed co-morbid condition (i.e. lung cancer, other lung disorder or disease), currently enrolled in a medical research study, non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AffloVest The Vest Arm<br>Devices placed on highest intensity / highest frequency | Device: International Biophysics AffloVest<br>* High-frequency chest wall oscillation vest<br>Device: Hill-Rom The Vest<br>* High-frequency chest wall oscillation vest<br>|
| Experimental: AffloVest inCourage Arm<br>Devices placed on highest intensity / highest frequency | Device: International Biophysics AffloVest<br>* High-frequency chest wall oscillation vest<br>Device: Respirtech inCourage<br>* High-frequency chest wall oscillation vest<br>|
| Experimental: AffloVest SmartVest Arm<br>Devices placed on highest intensity / highest frequency | Device: International Biophysics AffloVest<br>* High-frequency chest wall oscillation vest<br>Device: Electromed SmartVest<br>* High-frequency chest wall oscillation vest<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |