NCT03628456

Effect of HFCWO Vests on Spirometry Measurements

Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements, Comparative Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: International Biophysics Corporation · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 one (1) arm: • AffloVest® \& Monarch™ Within the arm, the order of products will be 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 Monarch) 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.

Conditions

• Cystic Fibrosis
• Bronchiectasis

Interventions

Type	Name	Description
DEVICE	International Biophysics AffloVest	High-frequency chest wall oscillation vest
DEVICE	Hill-Rom Monarch	High-frequency chest wall oscillation vest

Timeline

• Start date: 2018-09-13
• Primary completion: 2018-09-21
• Completion: 2019-07-02
• First posted: 2018-08-14
• Last updated: 2019-11-22
• Results posted: 2019-11-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study