Actively Recruiting
Ossiview Normative Mobility Data Collection Protocol
Led by Audioptics Medical Incorporated · Updated on 2024-08-01
120
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to learn about the sound-induced vibration level of certain structures in the middle ear in the normal-hearing population. The targeted structures are part of a chain of structures responsible for conducting sound within the auditory system and so their ability to vibrate normally in response to sound is relevant to the diagnosis of conductive hearing loss. The main questions the study aims to answer are: * What are the mean and variance of the normal sound-induced vibration level at two anatomical locations, the umbo of the malleus and the tip of the incus? * Are there any significant differences in these vibrational responses associated with sex or age? Participants will have their ossicular mobility measured with an investigational medical device that sends light into the middle ear and measures the motion-induced phase shift on light reflected from the target structures when a sound stimulus is presented. Standard hearing tests including audiometry and tympanometry will also be performed to confirm the normal hearing status of participants.
CONDITIONS
Official Title
Ossiview Normative Mobility Data Collection Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Normal hearing
- Age 18 years or older
- At least one of the incus or umbo visible during otoscopic examination
- Type A 226Hz tympanogram with peak static compliance between -99mmH20 and +50mmH20
- Peak static compliance range from 0.3 to 1.6 cc
You will not qualify if you...
- Audiometric air conduction thresholds above 40 dBHL at 500 Hz, 750 Hz, 1000 Hz, 1500 Hz, 2000 Hz, or 3000 Hz
- Audiometric air-bone gap greater than 5 dB at 500 Hz, 750 Hz, 1000 Hz, 1500 Hz, 2000 Hz, or 3000 Hz
- Ear infection within the past 3 months
- Middle ear surgery in the last 5 years
- Tympanic membrane perforation within the last 5 years
- Medical treatment for any ear-related disorder within the last 5 years
- Ear abnormalities found during otoscopy such as perforation, tympanosclerosis, otitis externa, thickened or fibrotic eardrum, mycosis, fluid, or infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Audioptics Medical
Halifax, Nova Scotia, Canada, B3H0A8
Actively Recruiting
Research Team
R
Robert Adamson, PhD
CONTACT
C
Cathy Creaser, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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