Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2018
CompletedFirst Submitted
Initial submission to the registry
May 14, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedResults Posted
Study results publicly available
September 6, 2018
CompletedOctober 3, 2018
September 1, 2018
24 days
May 14, 2018
August 9, 2018
September 5, 2018
Conditions
Outcome Measures
Primary Outcomes (5)
TV
Tidal Volume, the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied
30 minutes
PEF
Peak Expiratory Flow, a person's maximum speed of expiration
30 minutes
FVC
Forced Vital Capacity, the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible
30 minutes
FEV1
Forced Expiratory Volume, the volume of air that can be forced out in one second after taking a deep breath
30 minutes
FEF25-75%
Forced Expiratory Flow (25-75%), the peak expiratory flow at 25 - 75% FVC
30 minutes
Study Arms (3)
AffloVest The Vest Arm
EXPERIMENTALDevices placed on highest intensity / highest frequency
AffloVest inCourage Arm
EXPERIMENTALDevices placed on highest intensity / highest frequency
AffloVest SmartVest Arm
EXPERIMENTALDevices placed on highest intensity / highest frequency
Interventions
High-frequency chest wall oscillation vest
Eligibility Criteria
You may qualify if:
- Healthy subject, ages 18 - 50
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PDS Research
Kissimmee, Florida, 34741, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP of Engineering and Quality
- Organization
- International Biophysics Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas W O'Brien, MD
PDS Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2018
First Posted
May 23, 2018
Study Start
February 20, 2018
Primary Completion
March 16, 2018
Study Completion
March 16, 2018
Last Updated
October 3, 2018
Results First Posted
September 6, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share