CompletedNot Applicable

Study of Binaural Squelch Effect in Unilateral Otosclerosis

France25 participantsStarted 2018-03-06

Plain-language summary

Patients with unilateral transmission hypoacusis due to otosclerosis undergoing stapedectomy surgery will be prospectively included. They will be undergoing a free field vocal audiometry using the Oldenburg MATRIX software to evaluated the squelch effect gain between audiometry before and after 9months after surgery. Our hypothesis is to show a squelch effect with the rehabilitation of the binaural audition.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * diagnosis of otosclerosis * controlateral audiometry under 30dB loss * the ear to be operated with a transmission over 30dB Exclusion Criteria: * otosclerosis which has already operated on the ear studied * other cause of transmission hypoacusis * transmission after surgery other 30dB

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measure of squelch effect 9 months after surgery

Timeframe: 9 months

Trial details

NCT IDNCT03587792

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12-11

View on ClinicalTrials.gov More Otosclerosis of Middle Ear trials