Brief Title
Effect of HFCWO Vests on Spirometry Measurements
Official Title
Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements, Comparative Study
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.
Study Type
Interventional
Primary Outcome
Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices
Condition
Cystic Fibrosis
Intervention
International Biophysics AffloVest
Study Arms / Comparison Groups
AffloVest Monarch Arm
Description: Devices placed on highest intensity / highest frequency
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
10
Start Date
September 13, 2018
Completion Date
July 2, 2019
Primary Completion Date
September 21, 2018
Eligibility Criteria
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
Gender
All
Ages
18 Years - 50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Thomas W O'Brien, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03628456
Organization ID
2018-01
Responsible Party
Sponsor
Study Sponsor
International Biophysics Corporation
Study Sponsor
Thomas W O'Brien, MD, Principal Investigator, PDS Research
Verification Date
November 2019