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Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

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ClinicalTrials.gov Identifier: NCT03534986
Recruitment Status : Completed
First Posted : May 23, 2018
Results First Posted : September 6, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
International Biophysics Corporation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Bronchiectasis Device: International Biophysics AffloVest Device: Hill-Rom The Vest Device: Respirtech inCourage Device: Electromed SmartVest Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : March 16, 2018
Actual Study Completion Date : March 16, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AffloVest The Vest Arm
Devices placed on highest intensity / highest frequency
 Device: International Biophysics AffloVest
High-frequency chest wall oscillation vest

Device: Hill-Rom The Vest
High-frequency chest wall oscillation vest
Experimental: AffloVest inCourage Arm
Devices placed on highest intensity / highest frequency
 Device: International Biophysics AffloVest
High-frequency chest wall oscillation vest

Device: Respirtech inCourage
High-frequency chest wall oscillation vest
Experimental: AffloVest SmartVest Arm
Devices placed on highest intensity / highest frequency
 Device: International Biophysics AffloVest
High-frequency chest wall oscillation vest

Device: Electromed SmartVest
High-frequency chest wall oscillation vest


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. PEF [ Time Frame: 30 minutes ]
    Peak Expiratory Flow, a person's maximum speed of expiration

  3. 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

  4. 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

  5. FEF25-75% [ Time Frame: 30 minutes ]
    Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534986


Locations
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United States, Florida
PDS Research
Kissimmee, Florida, United States, 34741
Sponsors and Collaborators
International Biophysics Corporation
Investigators
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Principal Investigator: Thomas W O'Brien, MD PDS Research
  Study Documents (Full-Text)

Documents provided by International Biophysics Corporation:
Study Protocol and Statistical Analysis Plan  [PDF] April 18, 2018

More Information
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Responsible Party: International Biophysics Corporation
ClinicalTrials.gov Identifier: NCT03534986    
Other Study ID Numbers: 2017-02
First Posted: May 23, 2018    Key Record Dates
Results First Posted: September 6, 2018
Last Update Posted: October 3, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Cystic Fibrosis
Bronchiectasis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bronchial Diseases