Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

Cystic Fibrosis Clinical Trial

Official title:

Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03534986
• Other study ID #: 2017-02
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: March 16, 2018

Study information

• Verified date: September 2018
• Source: International Biophysics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Cystic Fibrosis

Intervention

Device:
• International Biophysics AffloVest
High-frequency chest wall oscillation vest
• Hill-Rom The Vest
High-frequency chest wall oscillation vest
• Respirtech inCourage
High-frequency chest wall oscillation vest
• Electromed SmartVest
High-frequency chest wall oscillation vest

Locations

Country	Name	City	State
United States	PDS Research	Kissimmee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
International Biophysics Corporation

Country where clinical trial is conducted

United States, 

Outcome

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