Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

Not Applicable

Completed

• Conditions: Cystic Fibrosis; Bronchiectasis
• Interventions: Device: International Biophysics AffloVest; Device: Electromed SmartVest; Device: Respirtech inCourage; Device: Hill-Rom The Vest

• Registration Number: NCT03534986
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-02-20
• Primary Completion: 2018-03-16
• Study Completion: 2018-03-16
• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-23
• Results First Submitted: 2018-08-09
• Results First Submitted QC: 2018-08-09
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Results First Posted: 2018-09-06
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AffloVest SmartVest Arm	Electromed SmartVest	Devices placed on highest intensity / highest frequency
AffloVest inCourage Arm	Respirtech inCourage	Devices placed on highest intensity / highest frequency
AffloVest inCourage Arm	International Biophysics AffloVest	Devices placed on highest intensity / highest frequency
AffloVest The Vest Arm	International Biophysics AffloVest	Devices placed on highest intensity / highest frequency
AffloVest SmartVest Arm	International Biophysics AffloVest	Devices placed on highest intensity / highest frequency
AffloVest The Vest Arm	Hill-Rom The Vest	Devices placed on highest intensity / highest frequency

Primary Outcome Measures

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

Trial Locations

Locations (1)

PDS Research; 🇺🇸 Kissimmee, Florida, United States