Ossiview Normative Mobility Data Collection Protocol

NCT06310278 | Recruiting

• 1 other identifier: 1030312
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Conductive Hearing Loss, Middle Ear

Keywords

optical coherence tomography

Outcome Measures

Primary Outcomes (2)

• Umbo mobility

  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

  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 Outcomes (1)

• Dependence on age and sex

  At study completion (6 months)

Study Arms (1)

Normal-hearing

Diagnostic Test: Ossicular mobility measurement

Interventions

Ossicular mobility measurement DIAGNOSTIC_TEST

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.

Normal-hearing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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+

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Audioptics Medical Incorporated: lead

Study Sites (1)

Audioptics Medical

Halifax, Nova Scotia, B3H0A8, Canada

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David P Morris, FRCS(Oto)

  Nova Scotia Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Adamson, PhD

CONTACT

902-497-8579; rob.adamson@audiopticsmedical.com

Cathy Creaser, MSc

CONTACT

cathy.creaser@audiopticsmedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 15, 2024
• Study Start: May 9, 2024
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)