Effect of HFCWO Vests on Spirometry Measurements

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Brief Title

Effect of HFCWO Vests on Spirometry Measurements

Official Title

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

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 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.

Study Type

Interventional

Primary Outcome

Tidal Volume (TV) Assessed in Participants at Baseline and With Both Devices

Condition

Cystic Fibrosis

Intervention

International Biophysics AffloVest

Study Arms / Comparison Groups

 AffloVest Monarch 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

10

Start Date

September 13, 2018

Completion Date

July 2, 2019

Primary Completion Date

September 21, 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

          -  presence of the following active implantable devices: pacemakers, neurostimulators,
             infusion pumps, circulatory support devices, implantable cardioverter defibrillators
             (ICD's), cochlear implants

          -  presence of head and/or neck injury that has not yet been stabilized

          -  presence of active hemorrhage with hemodynamic instability

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

NCT03628456

Organization ID

2018-01

Responsible Party

Sponsor

Study Sponsor

International Biophysics Corporation

Study Sponsor

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

Verification Date

November 2019