Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-20

Study Completion Date

2018-03-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis Bronchiectasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AffloVest The Vest Arm

Devices placed on highest intensity / highest frequency

Group Type EXPERIMENTAL