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Ossiview Normative Mobility Data Collection Protocol

NCT06310278 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2024-08-01

No results posted yet for this study

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.

Conditions

  • Conductive Hearing Loss, Middle Ear

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.

Sponsors & Collaborators

  • Audioptics Medical Incorporated

    lead INDUSTRY

Principal Investigators

  • David P Morris, FRCS(Oto) · Nova Scotia Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-09
Primary Completion
2024-10-31
Completion
2024-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06310278 on ClinicalTrials.gov