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Ossiview Normative Mobility Data Collection Protocol

ConditionConductive Hearing Loss, Middle Ear
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAudioptics Medical Incorporated

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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+

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Normal-hearing1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At study completion (6 months)
2

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.

Time frame
At study completion (6 months)

Secondary outcomes

1

Dependence on age and sex

p-values for dependence on age, sex and age-sex interaction at each stimulus frequency within two-way ANOVA.

Time frame
At study completion (6 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Audioptics Medical Incorporated

Lead sponsor

Source ClinicalTrials.gov
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