Ossiview Normative Mobility Data Collection Protocol

March 7, 2024 updated by: Audioptics Medical Incorporated

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Minimum 120 normal-hearing subjects including at least 10 male and 10 female subjects in each age group 18-30, 30-40, 40-50, 50-60 and 60+

Description

Inclusion Criteria:

  • Normal-hearing
  • Over the age of 18
  • At least one of incus or umbo visible under otoscopic examination
  • Type A 226Hz tympanogram with peak static compliance occurring at pressure between -99mmH20 and +50mmH20 and peak static compliance in the range from 0.3 to 1.6 cc

Exclusion Criteria:

  • Audiometric air conduction thresholds greater than 40 dBHL at 500 Hz, 750 Hz, 1000 Hz, 1500Hz, 2000 Hz, 3000 Hz
  • Audiometric air bone gap greater than 5dB at 500Hz, 750Hz, 1000Hz, 1500Hz, 2000Hz and 3000Hz
  • Self-reported history of ear infection in the previous 3 months
  • Self-reported history of middle ear surgery in the last 5 years
  • Self-reported history of tympanic membrane perforation within the last 5 years
  • Self-reported medical treatment for any ear-related disorder within the last 5 years
  • Evidence of perforation, tympanosclerosis, otitis externa, thickened or fibrotic eardrum, mycosis, fluid, infection or other ear abnormality under otoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal-hearing
Diagnostic test: Ossicular mobility measurement
Measurements of ossicular mobility i.e. the dynamic velocity of middle ear structures (umbo of malleus and incus at the incudostapedial joint) normalized to sound pressure incident on the tympanic membrane.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbo mobility
Time Frame: At study completion (6 months)
Estimated mean and variance of mobility in mm/s/Pa in the normal-hearing population measured at the umbo of the malleus at 500Hz, 750Hz, 1000Hz, 1500Hz, 2000Hz and 3000Hz stimulus frequencies.
At study completion (6 months)
Incus mobility
Time Frame: At study completion (6 months)
Estimated mean and variance of mobility in mm/s/Pa in the normal-hearing population measured at the incus lateral to the incudostapedial joint at 500Hz, 750Hz, 1000Hz, 1500Hz, 2000Hz and 3000Hz stimulus frequencies.
At study completion (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dependence on age and sex
Time Frame: At study completion (6 months)
p-values for dependence on age, sex and age-sex interaction at each stimulus frequency within two-way ANOVA.
At study completion (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Audioptics Medical Incorporated

Investigators

  • Principal Investigator: David P Morris, FRCS(Oto), Nova Scotia Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

March 2, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1030312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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