NCT07732920

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Aug 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

2.1 years

First QC Date

July 21, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

OCTvibrometry

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    2 years

  • Standard tympanometry--measurement of acoustic immittance in daPa

    Standard tympanometric testing of ear canal volume and middle ear immittance

    2 years

Study Arms (1)

Hearing loss

Other: OCT - clear

Interventions

OCT imaging and vibrometry

Hearing loss

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults ages 18+

You may qualify if:

  • Adults ages 18+ Conductive or sensorineural hearing loss -

You may not qualify if:

  • Adults with normal hearing Children Subjects unable to understand Informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zeiss Medical Technology/Audioptics Medical Incorporated

Halifax, Nova Scotia, B3J 0E9, Canada

Location

CDHA, Nova Scotia Health Authority, 3039-5820 University Avenue 3rd floor Dickson Centre Halifax NS B3H 1V7 Canada

Halifax, Nova Scotia, Canada

Location

Related Publications (1)

  • 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: 30870352BACKGROUND

MeSH Terms

Conditions

Hearing Loss, ConductiveHearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David P Morris, MD

    Nova Scotia Health Authority

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine L Creaser

CONTACT

Site operations manager

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 29, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations