Last reviewed · How we verify

NCT06310278

Ossiview Normative Mobility Data Collection Protocol

Recruiting now Last updated 1 August 2024
What this trial tests

trial testing Ossicular mobility measurement in Conductive Hearing Loss, Middle Ear in 120 participants. Currently enrolling.

Timeline
9 May 2024
Primary endpoint
31 October 2024
31 October 2024

Quick facts

Lead sponsorAudioptics Medical Incorporated
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment120
Start date9 May 2024
Primary completion31 October 2024
Estimated completion31 October 2024
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Audioptics Medical Incorporated

Who can join

18 and older, any sex, with Conductive Hearing Loss, Middle Ear. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06310278.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing