Study of Binaural Squelch Effect in Unilateral Otosclerosis (CBOU)

February 24, 2020 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Rhone Alpes Auvergne
      • Grenoble, Rhone Alpes Auvergne, France, 38000
        • University Hospital Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients undergoing a stapedectomy for unilateral disabled ear due to otosclerosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of squelch effect 9 months after surgery
Time Frame: 9 months
Speech reception threshold between S0N90 situation after and before surgery
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of shadow effect 9 months after surgery
Time Frame: 9 months
Comparison of Speech reception threshold between (S0N90) - (S0N-90) between 9months after surgery and before surgery
9 months
Measure of binaural benefit 9 months after surgery
Time Frame: 9 months
Comparison of Speech reception threshold S0N0 between 9months after surgery and before surgery
9 months
improving quality of life : Abbreviated Profile of Hearing Aid Benefit
Time Frame: 9 months
comparison of the global score and the four sub-scales: "aversiveness"; "reverberation"; "background noise"; "ease of communication" between 3 months after surgery and before surgery
9 months
Improving quality of life : Speech and Spatial Questionnaire
Time Frame: 9 months
comparison of the global score and the three sub-scale: "speech hearing"; "spatial hearing"; "qualities of hearing"
9 months
Measure of squelch effect 3 months after surgery
Time Frame: 3 months
Speech reception threshold between S0N90 situation after and before surgery
3 months
Measure of binaural benefit 3 months after surgery
Time Frame: 3 months
Comparison of Speech reception threshold S0N0 between 3 months after surgery and before surgery
3 months
Measure of shadow effect 3 months after surgery
Time Frame: 3 months
Comparison of Speech reception threshold between (S0N90) - (S0N-90) between 3 months after surgery and before surgery
3 months
improving quality of life : Abbreviated Profile of Hearing Aid Benefit
Time Frame: 3 months
comparison of the global score and the four sub-scale: "aversiveness"; "reverberation"; "background noise"; "ease of communication" between 3 months after surgery and before surgery
3 months
Improving quality of life : Speech and Spatial Questionnaire
Time Frame: 3 months
comparison of the global score and the three sub-scale: "speech hearing"; "spatial hearing"; "qualities of hearing" between 3 months after surgery and before surgery
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2018

Primary Completion (Actual)

December 11, 2019

Study Completion (Actual)

December 11, 2019

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

July 3, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC17.325
  • 2017-A02900-53 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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