Study Results
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View full resultsBasic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2018-09-13
2019-07-02
Brief Summary
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Detailed Description
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• 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Interventions
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International Biophysics AffloVest
High-frequency chest wall oscillation vest
Hill-Rom Monarch
High-frequency chest wall oscillation vest
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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International Biophysics Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas W O'Brien, MD
Role: PRINCIPAL_INVESTIGATOR
PDS Research
Locations
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PDS Research
Kissimmee, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018-01
Identifier Type: -
Identifier Source: org_study_id
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