Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2024-05-09
2024-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Normal-hearing
Ossicular mobility measurement
Measurements of ossicular mobility i.e. the dynamic velocity of middle ear structures (umbo of malleus and incus at the incudostapedial joint) normalized to sound pressure incident on the tympanic membrane.
Interventions
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Ossicular mobility measurement
Measurements of ossicular mobility i.e. the dynamic velocity of middle ear structures (umbo of malleus and incus at the incudostapedial joint) normalized to sound pressure incident on the tympanic membrane.
Eligibility Criteria
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Inclusion Criteria
* Over the age of 18
* At least one of incus or umbo visible under otoscopic examination
* Type A 226Hz tympanogram with peak static compliance occurring at pressure between -99mmH20 and +50mmH20 and peak static compliance in the range from 0.3 to 1.6 cc
Exclusion Criteria
* Audiometric air bone gap greater than 5dB at 500Hz, 750Hz, 1000Hz, 1500Hz, 2000Hz and 3000Hz
* Self-reported history of ear infection in the previous 3 months
* Self-reported history of middle ear surgery in the last 5 years
* Self-reported history of tympanic membrane perforation within the last 5 years
* Self-reported medical treatment for any ear-related disorder within the last 5 years
* Evidence of perforation, tympanosclerosis, otitis externa, thickened or fibrotic eardrum, mycosis, fluid, infection or other ear abnormality under otoscopy
18 Years
ALL
Yes
Sponsors
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Audioptics Medical Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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David P Morris, FRCS(Oto)
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health
Locations
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Audioptics Medical
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1030312
Identifier Type: -
Identifier Source: org_study_id
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