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Completed

NCT Number: NCT03628456

Effect of HFCWO Vests on Spirometry Measurements

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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Key information

Conditions

Cystic Fibrosis Bronchial Diseases Bronchiectasis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PDS Research

Kissimmee, Florida, 34741, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

International Biophysics AffloVest

Device

High-frequency chest wall oscillation vest

Hill-Rom Monarch

Device

High-frequency chest wall oscillation vest

Primary outcomes

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

    Time frame: 30 minutes

    Tidal Volume is the normal volume of air displaced between normal inhalation and exhalation, measured using standard sprirometry techniques

  2. Peak Expiratory Flow (PEF) Assessed in Participants at Baseline and With Both Devices

    Time frame: 30 minutes

    Peak Expiratory Flow (PEF) measures the peak flow during a forced exhalation, measured using standard spirometry techniques

  3. Forced Vital Capacity (FVC) Assessed in Participants at Baseline and With Both Devices

    Time frame: 30 minutes

    Forced Vital Capacity (FVC) is the total amount of air exhaled during the FEV test, measured using standard spirometry techniques

  4. Forced Expiratory Volume (1 Second) Assessed in Participants at Baseline and With Both Devices

    Time frame: 30 minutes

    Forced Expiratory Volume in 1 second (FEV1) measures how much air a person can exhale during a forced breath during the first one (1) second, measured using standard spirometry techniques

  5. Forced Expiratory Flow (FEF25-75%) Assessed in Participants at Baseline and With Both Devices

    Time frame: 30 minutes

    Forced Expiratory Flow (25-75%) is the average flow from the point at which 25% of the FVC has been exhaled to the point at which 75% of the FVC has been exhaled, measured using standard spirometry techniques

Sponsors and collaborators

Lead sponsor

International Biophysics Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 14, 2018
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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