Detecting Lung Infections Through Vibration
Feasibility and Optimization of High Frequency Oscillation (HFO) for Detection of Lung Infections
1 other identifier
observational
16
1 country
1
Brief Summary
The purpose of this study is to test a lung air vibrator device for vibrating air inside the lung. This exploratory diagnostic trial will test a novel and non-invasive means of detecting lower airway infections using exhaled breath sample.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2014
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
First Submitted
Initial submission to the registry
January 30, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedFirst Posted
Study publicly available on registry
February 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 16, 2016
March 1, 2016
1.8 years
January 30, 2014
March 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Optimal Operating Conditions for HFO Device
Following informed consent procedures, participants will be randomly assigned (much like a flip of a coin) to one of four experimental groups in order to test the effects of various frequencies of HFO on the size and concentration of particles obtained from EB. Group 1 (n=30) will receive 10 minutes of HFO at 15 Hz. Group 2 (n=30) will receive an identical course of HFO with the frequency set at 30 Hz. Group 3 (n=30) will receive HFO at 60 Hz and Group 4 (n=30) at 100 Hz. Participants will be tested on two separate days in order to systematically vary HFO intensity. Once again, much like a flip of a coin, each participant will be randomly assigned to receive HFO at either a low (0.75 cmH2O) or high (1.25 cm H2O) intensity on HFO Day 1. Participants receiving low intensity HFO on Day 1 will receive high intensity HFO on Day 2, and vice versa. Between HFO Testing Day 1 and 2 there will be a washout period of at least 24 hours.
6 months
Secondary Outcomes (1)
Particle size and distribution from exhaled breath
One year
Study Arms (5)
Group 1 will receive 15 Hz
Group 1 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 15 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 15 Hz at 1.25 cm.
Group 2 will receive 30 Hz
Group 2 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 30 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 30 Hz 1.25 cm.
Group 3 will receive 60 Hz
Group 3 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 60 Hz 2 .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 60 Hz at 1.25 cm.
Group 4 will receive 100 Hz
Group 4 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 100 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 100 Hz at 1.25 cm.
Phase II Optimal Frequency
Participants in Phase II will undergo 10 minutes of HFO at the optimal frequency as determined during Phase I.
Interventions
Group 1 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 15 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 15 Hz at 1.25 cm.
Group 2 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 30 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 30 Hz 1.25 cm.
Group 3 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 60 Hz .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 60 Hz at 1.25 cm.
Group 4 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 100 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 100 Hz at 1.25 cm.
Participants in Phase II will undergo 10 minutes of HFO at the optimal frequency as determined during Phase I.
Eligibility Criteria
Healthy normal adults age 18 to 50 Individuals with cystic fibrosis
You may qualify if:
- Age 18-50
You may not qualify if:
- History of major respiratory compromise (except cystic fibrosis if included within cystic fibrosis cohort)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin P Silverman, PhD
University of Florida
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2014
First Posted
February 6, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 16, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will share
Afshar-Mohajer N, Wu CY, Tsai HW, Silverman E, Davenport P, Hegde S. Optimizing an Internal Airway Percussion Device for Facilitating Exhalate Diagnostics of the Human Respiratory System. J Aerosol Med Pulm Drug Deliv. 2015 Mar 31. \[Epub ahead of print\] PubMed PMID: 25826647.