Effect of HFCWO Vests on Spirometry Measurements
Primary Purpose
Cystic Fibrosis, Bronchiectasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
International Biophysics AffloVest
Hill-Rom Monarch
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
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
Sites / Locations
- PDS Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AffloVest Monarch Arm
Arm Description
Devices placed on highest intensity / highest frequency
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03628456
First Posted
August 9, 2018
Last Updated
November 13, 2019
Sponsor
International Biophysics Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03628456
Brief Title
Effect of HFCWO Vests on Spirometry Measurements
Official Title
Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements, Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
September 21, 2018 (Actual)
Study Completion Date
July 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Biophysics Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Bronchiectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AffloVest Monarch Arm
Arm Type
Experimental
Arm Description
Devices placed on highest intensity / highest frequency
Intervention Type
Device
Intervention Name(s)
International Biophysics AffloVest
Intervention Description
High-frequency chest wall oscillation vest
Intervention Type
Device
Intervention Name(s)
Hill-Rom Monarch
Intervention Description
High-frequency chest wall oscillation vest
Primary Outcome Measure Information:
Title
Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices
Description
Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques
Time Frame
30 minutes
Title
Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices
Description
Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques
Time Frame
30 minutes
Title
Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices
Description
Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques
Time Frame
30 minutes
Title
Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices
Description
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
Time Frame
30 minutes
Title
Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices
Description
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
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas W O'Brien, MD
Organizational Affiliation
PDS Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
PDS Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of HFCWO Vests on Spirometry Measurements
We'll reach out to this number within 24 hrs