Conductive Hearing LossNCT07732920
Middle Ear Optical Coherence Tomography Imaging and Vibrometry in Patients With Hearing Loss
An observational study of Conductive Hearing Loss and Sensorineural Hearing Loss, run by Audioptics Medical Incorporated at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conductive Hearing Loss, Sensorineural Hearing Loss
- What is being tested?
- OCT - clear
- How many people
- 500 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Aug 2026to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults ages 18+
Who may be able to join
- Adults ages 18+ Conductive or sensorineural hearing loss -
Who cannot join
- Adults with normal hearing Children Subjects unable to understand Informed consent
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
Zeiss Medical Technology/Audioptics Medical Incorporated
Halifax, Nova Scotia, B3J 0E9
Catherine Creaser, 902-891-2891, catherine.creaser@zeiss.com
Site Operations Manager, 902-440-2895, carmen.mcknight@zeiss.com
CDHA, Nova Scotia Health Authority, 3039-5820 University Avenue 3rd floor Dickson Centre Halifax NS B3H 1V7 Canada
Halifax, Nova Scotia
Catherine Creaser, 902-891-2891, catherine.creaser@zeiss.com
Site operations manager, 902-891-2891, carmen.mcknight@zeiss.com
About this study
Official title: OCT Imaging and Vibrometry in Patients With Hearing Loss: A Pilot Study
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.
Read the 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.
- Being tested
- OCT - clear
- Keywords
- OCT, vibrometry
- Medical subject headings
- Hearing Loss, Conductive, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT - clearOther
OCT imaging and vibrometry
| Study group | Role | What they receive |
|---|---|---|
| Hearing loss | Not described Receives: Other: OCT - clear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vibrometry (Ossicular mobility in mm/s/Pa)
Optical Coherenece Tomography vibrometry measures of ossicular mobility for the umbo and incus in mm/s/Pa for 6 frequencies of 500, 750, 1000, 1500, 2000 and 3000 Hz
Measured: 2 years
Standard audiometry--threshold measurement in dBHL
Standard pure tone and bone conduction audiometry--measurement of acoustic thresholds for air and bone conductive stimuli at 250, 500, 1000, 2000, 3000 , 4000, 6000 and 8000 Hz
Measured: 2 years
Standard tympanometry--measurement of acoustic immittance in daPa
Standard tympanometric testing of ear canal volume and middle ear immittance
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conductive Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Audioptics Medical Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nova Scotia Health Authority, Dalhousie University
- Responsible party
- Sponsor
- Investigators
- David P Morris, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732920
- Sponsor's protocol ID
- TP-1868
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30870352
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCT Imaging and Vibrometry in Patients With Hearing Loss: A Pilot Study
- ClinicalTrials.gov ID
- NCT07732920
- Acronym / sponsor ID
- TP-1868
- Keywords
- OCT, vibrometry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Audioptics Medical IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Nova Scotia Health Authority, Dalhousie University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing loss | – | Other: OCT - clear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults ages 18+
Key inclusion criteria (1 listed)
- Adults ages 18+ Conductive or sensorineural hearing loss -
Key exclusion criteria (2 listed)
- Adults with normal hearing Children Subjects unable to understand Informed consent
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT - clearOCT imaging and vibrometry | Other | Hearing loss |
Primary outcome
Vibrometry (Ossicular mobility in mm/s/Pa)
Time frame: 2 years
Optical Coherenece Tomography vibrometry measures of ossicular mobility for the umbo and incus in mm/s/Pa for 6 frequencies of 500, 750, 1000, 1500, 2000 and 3000 Hz
Standard audiometry--threshold measurement in dBHL
Time frame: 2 years
Standard pure tone and bone conduction audiometry--measurement of acoustic thresholds for air and bone conductive stimuli at 250, 500, 1000, 2000, 3000 , 4000, 6000 and 8000 Hz
Standard tympanometry--measurement of acoustic immittance in daPa
Time frame: 2 years
Standard tympanometric testing of ear canal volume and middle ear immittance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 30870352MacDougall 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.
- Individual participant dataSharing planned: No
Related trials for Conductive Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Not yet recruiting
Outcomes of Cartilage Tympanoplasty in Children
Tympanic Membrane Perforation, Conductive Hearing Loss
Recruiting
Evaluation of Flexible Conductive Hearing Aids
Conductive Hearing Loss
RecruitingObservational study
Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Hearing Loss, Conductive, Hearing Loss, Mixed
Recruiting
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
Bone Conduction, Hearing Loss, Conductive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David P Morris, MD principal investigator
Nova Scotia Health Authority
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conductive Hearing Loss and Sensorineural Hearing Loss, run by Audioptics Medical Incorporated at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine L Creaser (902-891-2891, catherine.creaser@zeiss.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vibrometry (Ossicular mobility in mm/s/Pa) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07732920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.