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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
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
International Biophysics Corporation

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group 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

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
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: Arm 2
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: Arm 3
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



Primary Outcome Measures :
  1. Spirometry Measurements [ Time Frame: 30 minutes ]
    TV, PEF, FVC, FEV1, FEF25-75%



Information from the National Library of Medicine

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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

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
United States, Florida
PDS Research
Kissimmee, Florida, United States, 34741
Sponsors and Collaborators
International Biophysics Corporation
Investigators
Principal Investigator: Thomas W O'Brien, MD PDS Research

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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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