Trial Outcomes & Findings for Novel Protection Against Potential Brain, Hearing and Vision Injury During Blast Wave Exposure (NCT NCT03017924)
NCT ID: NCT03017924
Last Updated: 2021-02-16
Results Overview
The blast explosive waves experienced during the training during the N-back fMRI testing and the rs fMRI testing
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
single breacher training day
Results posted on
2021-02-16
Participant Flow
Participant milestones
| Measure |
Collar Group
Subjects that will wear the Q collar during the breacher training
Q collar: q-collar concussion prevention device
|
Non-Collar Group
Subjects that will not wear the Q collar during the breacher training
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Collar Group
n=12 Participants
Subjects that will wear the Q collar during the breacher training
Q collar: q-collar concussion prevention device
|
Non-Collar Group
n=11 Participants
Subjects that will not wear the Q collar during the breacher training
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.72 years
STANDARD_DEVIATION 6.79 • n=12 Participants
|
48.81 years
STANDARD_DEVIATION 10.37 • n=11 Participants
|
44.27 years
STANDARD_DEVIATION 8.58 • n=23 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=12 Participants
|
11 Participants
n=11 Participants
|
23 Participants
n=23 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
11 participants
n=11 Participants
|
23 participants
n=23 Participants
|
|
Weight
|
99.10 Kg
STANDARD_DEVIATION 17.58 • n=12 Participants
|
93.88 Kg
STANDARD_DEVIATION 15.10 • n=11 Participants
|
96.49 Kg
STANDARD_DEVIATION 16.34 • n=23 Participants
|
PRIMARY outcome
Timeframe: single breacher training dayPopulation: some subjects had head motion during the scan
The blast explosive waves experienced during the training during the N-back fMRI testing and the rs fMRI testing
Outcome measures
| Measure |
Collar Group
n=10 Participants
Subjects that will wear the Q collar during the breacher training
Q collar: q-collar concussion prevention device
|
Non-Collar Group
n=9 Participants
Subjects that will not wear the Q collar during the breacher training
|
|---|---|---|
|
Blast Explosive Waves Experienced During the Training
Number of blasts N-Back fMRI
|
4.11 number of blasts
Standard Deviation 3.37
|
4.29 number of blasts
Standard Deviation 2.06
|
|
Blast Explosive Waves Experienced During the Training
Number of blasts rs fMRI
|
4.20 number of blasts
Standard Deviation 3.19
|
4.0 number of blasts
Standard Deviation 2.12
|
PRIMARY outcome
Timeframe: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.Population: some subjects had head motion
between group differences in average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI
Outcome measures
| Measure |
Collar Group
n=10 Participants
Subjects that will wear the Q collar during the breacher training
Q collar: q-collar concussion prevention device
|
Non-Collar Group
n=9 Participants
Subjects that will not wear the Q collar during the breacher training
|
|---|---|---|
|
Average Peak Pressure Differences Between Groups
rs fMRI Average peak pressure (psi)
|
1.67 pounds per square inch
Standard Deviation 0.42
|
1.81 pounds per square inch
Standard Deviation 0.53
|
|
Average Peak Pressure Differences Between Groups
N-Back fMRI Average peak pressure (psi)
|
1.67 pounds per square inch
Standard Deviation 0.44
|
1.99 pounds per square inch
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.Population: All subject data available for this measure - no data lost due to head motion
between group differences in total impulse pre to post in collar versus no collar in both the n-back fMRI and the rs fMRI testing conditions
Outcome measures
| Measure |
Collar Group
n=10 Participants
Subjects that will wear the Q collar during the breacher training
Q collar: q-collar concussion prevention device
|
Non-Collar Group
n=9 Participants
Subjects that will not wear the Q collar during the breacher training
|
|---|---|---|
|
Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar
n-Back fMRI total impulse
|
6.58 units on a scale (psi*ms)
Standard Deviation 4.19
|
7.67 units on a scale (psi*ms)
Standard Deviation 3.31
|
|
Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar
rs FMRI total impulse
|
6.9 units on a scale (psi*ms)
Standard Deviation 4.08
|
6.95 units on a scale (psi*ms)
Standard Deviation 3.66
|
SECONDARY outcome
Timeframe: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.Population: all subject data available for this analysis
pre to post training change in the DP-NF value (the dB difference between the distortion product emission and the noise floor amplitudes) between the collar and no collar groups reported in Hz
Outcome measures
| Measure |
Collar Group
n=10 Participants
Subjects that will wear the Q collar during the breacher training
Q collar: q-collar concussion prevention device
|
Non-Collar Group
n=9 Participants
Subjects that will not wear the Q collar during the breacher training
|
|---|---|---|
|
Change in DP-NF Value (Reported in Hz)
8000 Hz left
|
1.13 Change in pre to post Dp (reported in Hz
Standard Deviation 12.21
|
4.23 Change in pre to post Dp (reported in Hz
Standard Deviation 9.61
|
|
Change in DP-NF Value (Reported in Hz)
2000 Hz right
|
0.98 Change in pre to post Dp (reported in Hz
Standard Deviation 5.10
|
0.64 Change in pre to post Dp (reported in Hz
Standard Deviation 3.61
|
|
Change in DP-NF Value (Reported in Hz)
2000 Hz Left
|
1.64 Change in pre to post Dp (reported in Hz
Standard Deviation 6.91
|
-0.5 Change in pre to post Dp (reported in Hz
Standard Deviation 6.91
|
|
Change in DP-NF Value (Reported in Hz)
3000 Hz Right
|
5.15 Change in pre to post Dp (reported in Hz
Standard Deviation 11.36
|
-1.44 Change in pre to post Dp (reported in Hz
Standard Deviation 6.47
|
|
Change in DP-NF Value (Reported in Hz)
3000 Hz Left
|
2.81 Change in pre to post Dp (reported in Hz
Standard Deviation 10.28
|
-1.29 Change in pre to post Dp (reported in Hz
Standard Deviation 10.42
|
|
Change in DP-NF Value (Reported in Hz)
4000 Hz right
|
5.63 Change in pre to post Dp (reported in Hz
Standard Deviation 6.48
|
-2.01 Change in pre to post Dp (reported in Hz
Standard Deviation 6.85
|
|
Change in DP-NF Value (Reported in Hz)
4000 Hz left
|
1.54 Change in pre to post Dp (reported in Hz
Standard Deviation 7.57
|
2.57 Change in pre to post Dp (reported in Hz
Standard Deviation 6.50
|
|
Change in DP-NF Value (Reported in Hz)
6000 Hz right
|
1.93 Change in pre to post Dp (reported in Hz
Standard Deviation 10.40
|
-1.29 Change in pre to post Dp (reported in Hz
Standard Deviation 8.88
|
|
Change in DP-NF Value (Reported in Hz)
6000 Hz left
|
-1.68 Change in pre to post Dp (reported in Hz
Standard Deviation 9.6
|
3.55 Change in pre to post Dp (reported in Hz
Standard Deviation 9.24
|
|
Change in DP-NF Value (Reported in Hz)
8000 Hz right
|
1.43 Change in pre to post Dp (reported in Hz
Standard Deviation 6.97
|
1.54 Change in pre to post Dp (reported in Hz
Standard Deviation 12.52
|
Adverse Events
Collar Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Collar Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place