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Study of Binaural Squelch Effect in Unilateral Otosclerosis

Study of Binaural Squelch Effect Among Patients Undergoing Unilateral Otosclerosis Surgery: Comparison of Understanding in Noise Before-after Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03587792
Acronym
CBOU
Enrollment
25
Registered
2018-07-16
Start date
2018-03-06
Completion date
2019-12-11
Last updated
2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otosclerosis of Middle Ear, Unilateral Hearing Loss

Brief 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.

Detailed description

Otosclerosis is one of the main causes of transmission hypoacusis. It can be treated with stapedectomy surgery. But the understanding ability in noise has not been really studied. The Oldenburg MATRIX test is a well know test in audiology and allow to study the understanding in noise. This study included all the patients coming in our center for stapedectomy for otosclerosis with controlateral audition under 30 decibels (dB) loss. They will all undergo the MATRIX test in three situations: vocal material and noise from the front of the patient (S0N0 situation); vocal material from the front and noise from the bad-earing side (S0N-90 situation); vocal material from the front and noise from the good-earing side (S0N90 situation). This might give three informations: -Squelch effect which is the difference between Speech Reception Threshold (SRT) in S0N90 situation at 9month after surgery and before surgery. The squelch effect is the ability of cortical discrimination to extract spatial cues and information providing from two different sources. So we considered the situation before surgery as a unilateral condition and the surgery rehabilitation as a bilateral condition. * Head Shadow effect which is the difference between S0N90 and S0N-90 audiometry situations. The head shadow effect is the difference in the Speech Reception Threshold (SRT) due to diffraction effect of the physical sound wave. * Binaural benefit which is the difference between S0N0 situation after and before surgery. The binaural benefit is the SRT gain of both ear with same threshold comparing to a gap of threshold between the two ears. The patients will also filled two questionnaires of quality of life: Abbreviated Profile of Hearing Aid Benefit (APHAB) and Speech and Spatial Questionnaire (SSQ). The aim is to show the benefit of the surgery in otosclerosis for comprehension in noise.

Interventions

PROCEDUREstapedectomy

Stapedectomy as described in literature with stapes removal, Carbon Dioxide (CO2) laser platinectomy and placement of a prothesis(piston) between the incus long process and the stapes footplate

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of squelch effect 9 months after surgery9 monthsSpeech reception threshold between S0N90 situation after and before surgery

Secondary

MeasureTime frameDescription
Measure of binaural benefit 9 months after surgery9 monthsComparison of Speech reception threshold S0N0 between 9months after surgery and before surgery
improving quality of life : Abbreviated Profile of Hearing Aid Benefit9 monthscomparison of the global score and the four sub-scales: aversiveness; reverberation; background noise; ease of communication between 3 months after surgery and before surgery
Improving quality of life : Speech and Spatial Questionnaire9 monthscomparison of the global score and the three sub-scale: speech hearing; spatial hearing; qualities of hearing
Measure of shadow effect 9 months after surgery9 monthsComparison of Speech reception threshold between (S0N90) - (S0N-90) between 9months after surgery and before surgery
Measure of binaural benefit 3 months after surgery3 monthsComparison of Speech reception threshold S0N0 between 3 months after surgery and before surgery
Measure of shadow effect 3 months after surgery3 monthsComparison of Speech reception threshold between (S0N90) - (S0N-90) between 3 months after surgery and before surgery
Measure of squelch effect 3 months after surgery3 monthsSpeech reception threshold between S0N90 situation after and before surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026