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RECRUITING
NCT06310278

Ossiview Normative Mobility Data Collection Protocol

Sponsor: Audioptics Medical Incorporated

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2024-05-09

Completion Date

2024-10-31

Last Updated

2024-08-01

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

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.

Locations (1)

Audioptics Medical

Halifax, Nova Scotia, Canada