Collecting normal mobility data of middle ear structures
Ossiview Normative Mobility Data Collection Protocol
Audioptics Medical Incorporated · NCT06310278
This study is trying to collect information on how well certain parts of the middle ear move in people with normal hearing to see if age and sex make a difference.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Audioptics Medical Incorporated (industry) |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT06310278 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the sound-induced vibration levels of specific structures in the middle ear among individuals with normal hearing. It focuses on measuring the ossicular mobility at the umbo of the malleus and the tip of the incus using an investigational device that utilizes optical coherence tomography. The study will also explore potential differences in vibrational responses based on age and sex. Participants will undergo standard hearing tests alongside the mobility measurements to ensure eligibility.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with normal hearing and visible incus or umbo during examination.
Not a fit: Patients with a history of ear infections, surgeries, or any ear abnormalities are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of normal middle ear function, aiding in the diagnosis of conductive hearing loss.
How similar studies have performed: While similar studies have explored middle ear function, this specific approach using optical coherence tomography for ossicular mobility measurement is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Halifax, Nova Scotia
- Audioptics Medical — Halifax, Nova Scotia, Canada (RECRUITING)
Study contacts
- Principal investigator: David P Morris, FRCS(Oto) — Nova Scotia Health
- Study coordinator: Robert Adamson, PhD
- Email: rob.adamson@audiopticsmedical.com
- Phone: 902-497-8579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Conductive Hearing Loss, Middle Ear, optical coherence tomography