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Completed

NCT Number: NCT03587792

Study of Binaural Squelch Effect in Unilateral Otosclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Grenoble

Grenoble, Rhone Alpes Auvergne, 38000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stapedectomy

Procedure

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

Other names: platinectomy

Primary outcomes

  1. Measure of squelch effect 9 months after surgery

    Time frame: 9 months

    Speech reception threshold between S0N90 situation after and before surgery

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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"

  5. Measure of squelch effect 3 months after surgery

    Time frame: 3 months

    Speech reception threshold between S0N90 situation after and before surgery

  6. 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

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: CBOU

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 16, 2018
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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