- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02262507
Concussion Device Audiological Measures
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For the testing sessions, subjects may either come to our testing site or the investigators may bring the testing to their location (e.g. 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veins are reduced, while flow within the carotid arteries and all portions of the cerebrum are preserved (JA Fisher, unpublished data).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 subject's 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Normal healthy volunteer
- Able to provide written consent
Exclusion Criteria:
• Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or head trauma
- Hydrocephalus
- Known carotid hypersensitivity
- Known increased intracranial pressure
- Central vein thrombosis
- Active concussion symptoms
- Ventricular shunt or neurologic condition
- Internal or external hardware that has been surgically placed in the neck
- Any altered level of consciousness
- Inability to sit still for 10 minutes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Device wearing
All subjects who meet the study criteria and volunteer to participate will be included in the study.
Subjects will undergo repeat oto-acoustic measures both wearing the device and not wearing the device.
The intervention will be the auto-acoustic measurement - taken while wearing the collar and then again when not wearing the collar.
|
Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins.
Each subject will undergo repeat oto-acoustic measures both wearing the device and not wearing the device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Undergoing Acoustic Reflectance
Time Frame: within single day
|
Number of participants undergoing acoustic reflectance with and without the compression collar
|
within single day
|
Collaborators and Investigators
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-5717
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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