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NCT Number: NCT06310278

Ossiview Normative Mobility Data Collection Protocol

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cathy Creaser, MSc

CONTACT

[email protected]

Robert Adamson, PhD

CONTACT

[email protected]

902-497-8579

Sponsors and collaborators

Lead sponsor

Audioptics Medical Incorporated

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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