search
Back to results

Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

Primary Purpose

Cystic Fibrosis, Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
International Biophysics AffloVest
Hill-Rom The Vest
Respirtech inCourage
Electromed SmartVest
Sponsored by
International Biophysics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • PDS Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

AffloVest The Vest Arm

AffloVest inCourage Arm

AffloVest SmartVest Arm

Arm Description

Devices placed on highest intensity / highest frequency

Devices placed on highest intensity / highest frequency

Devices placed on highest intensity / highest frequency

Outcomes

Primary Outcome Measures

TV
Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied
PEF
Peak Expiratory Flow, a person's maximum speed of expiration
FVC
Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible
FEV1
Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath
FEF25-75%
Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC

Secondary Outcome Measures

Full Information

First Posted
May 14, 2018
Last Updated
September 5, 2018
Sponsor
International Biophysics Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT03534986
Brief Title
Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements
Official Title
Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
March 16, 2018 (Actual)
Study Completion Date
March 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Biophysics Corporation

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Bronchiectasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AffloVest The Vest Arm
Arm Type
Experimental
Arm Description
Devices placed on highest intensity / highest frequency
Arm Title
AffloVest inCourage Arm
Arm Type
Experimental
Arm Description
Devices placed on highest intensity / highest frequency
Arm Title
AffloVest SmartVest Arm
Arm Type
Experimental
Arm Description
Devices placed on highest intensity / highest frequency
Intervention Type
Device
Intervention Name(s)
International Biophysics AffloVest
Intervention Description
High-frequency chest wall oscillation vest
Intervention Type
Device
Intervention Name(s)
Hill-Rom The Vest
Intervention Description
High-frequency chest wall oscillation vest
Intervention Type
Device
Intervention Name(s)
Respirtech inCourage
Intervention Description
High-frequency chest wall oscillation vest
Intervention Type
Device
Intervention Name(s)
Electromed SmartVest
Intervention Description
High-frequency chest wall oscillation vest
Primary Outcome Measure Information:
Title
TV
Description
Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied
Time Frame
30 minutes
Title
PEF
Description
Peak Expiratory Flow, a person's maximum speed of expiration
Time Frame
30 minutes
Title
FVC
Description
Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible
Time Frame
30 minutes
Title
FEV1
Description
Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath
Time Frame
30 minutes
Title
FEF25-75%
Description
Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas W O'Brien, MD
Organizational Affiliation
PDS Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
PDS Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

We'll reach out to this number within 24 hrs