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NCT06310278
Ossiview Normative Mobility Data Collection Protocol
trial testing Ossicular mobility measurement in Conductive Hearing Loss, Middle Ear in 120 participants. Currently enrolling.
31 October 2024
Quick facts
| Lead sponsor | Audioptics Medical Incorporated |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 9 May 2024 |
| Primary completion | 31 October 2024 |
| Estimated completion | 31 October 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Ossicular mobility measurement
Conditions studied
- Conductive Hearing Loss, Middle Ear — all drugs for Conductive Hearing Loss, Middle Ear →
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.
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- PubMed search for NCT06310278
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06310278 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Audioptics Medical Incorporated
- Last refreshed: 1 August 2024
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