Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements
September 5, 2018 updated by: International Biophysics Corporation
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.
Study Overview
Status
Completed
Conditions
Detailed Description
The study will be broken into three (3) arms:
- AffloVest® & The Vest®
- AffloVest® & inCourage®
- AffloVest® & SmartVest® Subjects will be randomly assigned to an arm. Within each arm, the order of products will be also 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 Compressor-based vest) 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
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Kissimmee, Florida, United States, 34741
- PDS Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AffloVest The Vest Arm
Devices placed on highest intensity / highest frequency
|
High-frequency chest wall oscillation vest
High-frequency chest wall oscillation vest
|
|
Experimental: AffloVest inCourage Arm
Devices placed on highest intensity / highest frequency
|
High-frequency chest wall oscillation vest
High-frequency chest wall oscillation vest
|
|
Experimental: AffloVest SmartVest Arm
Devices placed on highest intensity / highest frequency
|
High-frequency chest wall oscillation vest
High-frequency chest wall oscillation vest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TV
Time Frame: 30 minutes
|
Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied
|
30 minutes
|
|
PEF
Time Frame: 30 minutes
|
Peak Expiratory Flow, a person's maximum speed of expiration
|
30 minutes
|
|
FVC
Time Frame: 30 minutes
|
Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible
|
30 minutes
|
|
FEV1
Time Frame: 30 minutes
|
Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath
|
30 minutes
|
|
FEF25-75%
Time Frame: 30 minutes
|
Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas W O'Brien, MD, PDS Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2018
Primary Completion (Actual)
March 16, 2018
Study Completion (Actual)
March 16, 2018
Study Registration Dates
First Submitted
May 14, 2018
First Submitted That Met QC Criteria
May 14, 2018
First Posted (Actual)
May 23, 2018
Study Record Updates
Last Update Posted (Actual)
October 3, 2018
Last Update Submitted That Met QC Criteria
September 5, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.