Effect of HFCWO Vests on Spirometry Measurements

Not Applicable

Completed

Interventions: Device: International Biophysics AffloVest
Device: Hill-Rom Monarch

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
AffloVest Monarch Arm	International Biophysics AffloVest	Devices placed on highest intensity / highest frequency
AffloVest Monarch Arm	Hill-Rom Monarch	Devices placed on highest intensity / highest frequency

Primary Outcome Measures

Name	Time	Method
Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices	30 minutes	Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques
Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices	30 minutes	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
Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices	30 minutes	Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques
Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices	30 minutes	Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques
Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices	30 minutes	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