Effect of HFCWO 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 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.

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

Conditions
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Cystic Fibrosis, Bronchiectasis

Intervention / Treatment
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* Device: International Biophysics AffloVest
* Device: Hill-Rom Monarch


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 presence of the following active implantable devices: pacemakers, neurostimulators, infusion pumps, circulatory support devices, implantable cardioverter defibrillators (ICD's), cochlear implants presence of head and/or neck injury that has not yet been stabilized presence of active hemorrhage with hemodynamic instability

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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