Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

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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

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 Type

Interventional

Primary Outcome

TV

Condition

Cystic Fibrosis

Intervention

International Biophysics AffloVest

Study Arms / Comparison Groups

 AffloVest The Vest Arm
Description:  Devices placed on highest intensity / highest frequency

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

32

Start Date

February 20, 2018

Completion Date

March 16, 2018

Primary Completion Date

March 16, 2018

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

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Thomas W O'Brien, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03534986

Organization ID

2017-02

Responsible Party

Sponsor

Study Sponsor

International Biophysics Corporation

Study Sponsor

Thomas W O'Brien, MD, Principal Investigator, PDS Research

Verification Date

September 2018