- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02056860
Detecting Lung Infections Through Vibration
Feasibility and Optimization of High Frequency Oscillation (HFO) for Detection of Lung Infections
Study Overview
Status
Conditions
Detailed Description
This study has two phases. Once the subject has consented phase 1 will start by the subject breathing air out of their lungs into the device. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air.
In phase 2, the subjects will breathe air out of their lungs into the device for 15 minutes. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air for 15 minutes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18-50
Exclusion Criteria:
- History of major respiratory compromise (except cystic fibrosis if included within cystic fibrosis cohort)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 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 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 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 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.
|
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.
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Participants in Phase II will undergo 10 minutes of HFO at the optimal frequency as determined during Phase I.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimal Operating Conditions for HFO Device
Time Frame: 6 months
|
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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Particle size and distribution from exhaled breath
Time Frame: One year
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The exhaled air will be directed to a culturing media in place of the Sizer for collection of the droplets during two conditions: tidal breathing without oscillation (control) and tidal breathing with oscillation (experimental).
The samples collected in the medium will later be cultured in a lab to determine the microbial species and their abundances.
The purpose of Phase II experiments is to characterize the biological constituents produced from the oscillation enhanced sampling and contrast these constituents with those obtained during non-oscillation enhanced sampling.
We hope to determine if the addition of oscillation increases the variety and abundance of microbial species able to be extracted from exhaled breath.
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One year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Erin P Silverman, PhD, University of Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 821-2013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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