Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

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: Bronchiectasis; Cystic Fibrosis
• Intervention / Treatment: Device: International Biophysics AffloVest; Device: Hill-Rom The Vest; Device: Respirtech inCourage; Device: Electromed SmartVest

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

Study Locations

• United States
  • Florida
    • Kissimmee, Florida, United States, 34741
      • PDS Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TV	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	Peak Expiratory Flow, a person's maximum speed of expiration	30 minutes
FVC	Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible	30 minutes
FEV1	Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath	30 minutes
FEF25-75%	Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC	30 minutes

Collaborators and Investigators

• Sponsor: International Biophysics Corporation
• Investigators: Principal Investigator: Thomas W O'Brien, MD, PDS Research

Study record dates

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: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Bronchial Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Bronchiectasis; Cystic Fibrosis
• 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