Middle Ear Optical Coherence Tomography Imaging and Vibrometry in Patients With Hearing Loss
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OCT - clear.
- Who it may be relevant to
- Registry conditions: Conductive Hearing Loss, Sensorineural Hearing Loss. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
OCT Imaging and Vibrometry in Patients With Hearing Loss: A Pilot Study
Overview
This study involves imaging ears with hearing loss with a new system that allows the user to see the middle ear bones and measure their movement in response to sound.
Detailed description
This study is an exploratory clinical investigation to obtain pilot imaging and vibrometry data in patients with various hearing loss aetiologies and to identify qualitative and quantitative features associated with specific pathologies. The data collected in this study is intended to support future investigations into the accuracy of the system in diagnosing specific middle ear disorders.
Interventions
- Other OCT - clear
OCT imaging and vibrometry
Primary outcome measures
- Vibrometry (Ossicular mobility in mm/s/Pa) [Time frame: 2 years]
- Standard audiometry--threshold measurement in dBHL [Time frame: 2 years]
- Standard tympanometry--measurement of acoustic immittance in daPa [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
Adults ages 18+ Conductive or sensorineural hearing loss -
Exclusion criteria
Adults with normal hearing Children Subjects unable to understand Informed consent
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Canada · 2 centers
- Zeiss Medical Technology/Audioptics Medical Incorporated — Halifax
- CDHA, Nova Scotia Health Authority, 3039-5820 University Avenue 3rd floor Dickson Centre H — Halifax
Publications
- MacDougall D, Morrison L, Morrison C, Morris DP, Bance M, Adamson RBA. Optical Coherence Tomography Doppler Vibrometry Measurement of Stapes Vibration in Patients With Stapes Fixation and Normal Controls. Otol Neurotol. 2019 Apr;40(4):e349-e355. doi: 10.1097/MAO.0000000000002193. PMID 30870352
Identifiers
NCT: NCT07732920 · TP-1868