Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	International Biophysics Corporation
ClinicalTrials.gov Identifier:	NCT03534986 History of Changes
Other Study ID Numbers:	2017-02
First Posted:	May 23, 2018
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