Ignite Creation Date:
2024-05-06 @ 3:20 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02262507
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2014-10-03
Brief Title:
Concussion Device Audiological Measures
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Concussion Device Audiological Measures
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Significant morbidity mortality and related costs are caused by traumatic brain injury TBI A simple effective and lightweight device worn by athletes or war fighters in the field designed to mitigate TBI resulting from blast trauma or concussive events would save lives and the huge costs currently being experienced for life-treatment of surviving victims An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver the Device is being developed by Q30 Labs LLC Q30 Initial research suggests that the Device has the potential to reduce the likelihood of TBI The rationale for testing wideband absorbance and Oto-acoustics emissions OAE is that the investigators need a physiologic non-invasive method to evaluate the brain responses to mild jugular compression across multiple age groups To determine this with MR imaging is currently cost prohibitive The investigators pilot data from the parent IRB indicates a consistent response measured via wideband absorbance in young adults Therefore a preliminary step to evaluate the safety and efficacy of the neck collar device is to employ this technology across a wide range of ages
Detailed Description:
For the testing sessions subjects may either come to our testing site or the investigators may bring the testing to their location eg schools work The subjects will be fitted with a device around your neck like a neck tie The Device incorporates two bulges localized over the site of the internal jugular veins bilaterally Experiments performed with jugular Doppler ultrasound demonstrate that while wearing the Device flows within the jugular veins are reduced while flow within the carotid arteries and all portions of the cerebrum are preserved JA Fisher unpublished data Thus application of the Device to the subject will not cause any untoward health risks IRB 2013-2240 safety testing performed on this Device The pressure exerted by the Device on the region of the neck superficial to the internal jugular vein is akin to the pressure felt when a person yawns or wears a snugly fitting necktie The methods are utilized in prior approved IRB 2013-2240
Station I Consent to Participate Each participant will review the Institutional Review Board approved consent to participate form prior to data collection They will be given an adequate amount of time to ask questions to the study coordinator or the person obtaining consent and then make their decision to participate or not participate If they wish to participate they will be asked to sign the informed consent form For middle school and high school subjects recruited via the investigators relationship with the schools this station will be designated to review consent and assent forms to ensure that proper signatures have been obtained
Station II Device Fitting and Ultrasound The subjects will be outfitted with the device by a staff member appropriately trained in fitting the device in the proper location
Station III Wideband Absorbance and Oto-Acoustic Emissions This station will help determine the effectiveness of the device by measuring the auditory response of a clicking noise that will be non-invasively imparted into the subjects outer ear For both tests a soft silicone tip is placed into the outer ear and sounds are delivered via a miniature speaker For the wideband absorbance test absorbed acoustic responses will be monitored to provide information on the operation of the collar device These are measured as changes in the acoustic absorbance of the ear For the oto-acoustic emission test tones or clicks will be presented to the ear with the same soft ear probe and recording microphones pick up the oto-acoustic emission coming back from the outer hair cells of the inner ear The computer averages and processes the responses in reference to a noise floor across a specified frequency range displaying the results on the computer screen for the tester The oto-acoustic emissions test also provides a brief hearing screening to determine if hearing is normal
Evidence indicates that wideband absorbance and oto-acoustic emissions will be altered with increased intracranial pressure thus this simple non-invasive exam will provide feedback on the effectiveness of the device
During the wideband absorbance and oto-acoustic emissions testing the study participants will also be fitted with a compressive circumferential neck collar which can provide variable and specific levels of pressure The pressure is achieved by inflatable pods that sit adjacent to the trachea affixed to a non-stretch adjustable collar Manual inflation is regulated and monitored by an experience operator technician through a bulb style pump and an electronic gauge Testing will occur without pressure and then with pressures applied up to 40mmHg
Station IV Hearing Assessment Otoscopy will be performed by an audiologist to note any ear blockages such as wax or drainage for exclusion purposes The oto-acoustic emissions test will be interpreted to determine if normal responses were obtained in each ear If abnormal a hearing screening using pure tone audiometry screening will be provided free of charge In the event that the hearing screening is determined to be abnormal the subject will receive the results which may be shared with their primary care provider to determine any need for referral for follow-up If a subject is seen for follow-up at CCHMC following an abnormal hearing assessment this visit and any follow up visits will not be paid for by this project and will be subject to insurance billing
Station I Consent to Participate Each participant will review the Institutional Review Board approved consent to participate form prior to data collection They will be given an adequate amount of time to ask questions to the study coordinator or the person obtaining consent and then make their decision to participate or not participate If they wish to participate they will be asked to sign the informed consent form For middle school and high school subjects recruited via the investigators relationship with the schools this station will be designated to review consent and assent forms to ensure that proper signatures have been obtained
Station II Device Fitting and Ultrasound The subjects will be outfitted with the device by a staff member appropriately trained in fitting the device in the proper location
Station III Wideband Absorbance and Oto-Acoustic Emissions This station will help determine the effectiveness of the device by measuring the auditory response of a clicking noise that will be non-invasively imparted into the subjects outer ear For both tests a soft silicone tip is placed into the outer ear and sounds are delivered via a miniature speaker For the wideband absorbance test absorbed acoustic responses will be monitored to provide information on the operation of the collar device These are measured as changes in the acoustic absorbance of the ear For the oto-acoustic emission test tones or clicks will be presented to the ear with the same soft ear probe and recording microphones pick up the oto-acoustic emission coming back from the outer hair cells of the inner ear The computer averages and processes the responses in reference to a noise floor across a specified frequency range displaying the results on the computer screen for the tester The oto-acoustic emissions test also provides a brief hearing screening to determine if hearing is normal
Evidence indicates that wideband absorbance and oto-acoustic emissions will be altered with increased intracranial pressure thus this simple non-invasive exam will provide feedback on the effectiveness of the device
During the wideband absorbance and oto-acoustic emissions testing the study participants will also be fitted with a compressive circumferential neck collar which can provide variable and specific levels of pressure The pressure is achieved by inflatable pods that sit adjacent to the trachea affixed to a non-stretch adjustable collar Manual inflation is regulated and monitored by an experience operator technician through a bulb style pump and an electronic gauge Testing will occur without pressure and then with pressures applied up to 40mmHg
Station IV Hearing Assessment Otoscopy will be performed by an audiologist to note any ear blockages such as wax or drainage for exclusion purposes The oto-acoustic emissions test will be interpreted to determine if normal responses were obtained in each ear If abnormal a hearing screening using pure tone audiometry screening will be provided free of charge In the event that the hearing screening is determined to be abnormal the subject will receive the results which may be shared with their primary care provider to determine any need for referral for follow-up If a subject is seen for follow-up at CCHMC following an abnormal hearing assessment this visit and any follow up visits will not be paid for by this project and will be subject to insurance billing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None