Study of Binaural Squelch Effect in Unilateral Otosclerosis

Unilateral Hearing Loss Clinical Trial

— CBOU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03587792
• Other study ID #: 38RC17.325
• Secondary ID: 2017-A02900-53
• Status: Completed
• Start date: March 6, 2018
• Est. completion date: December 11, 2019

Study information

• Verified date: February 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 11, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Unilateral
• Otosclerosis
• Otosclerosis of Middle Ear
• Unilateral Hearing Loss

Intervention

Procedure:
• stapedectomy
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

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble	Rhone Alpes Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (14)

Avan P, Giraudet F, Büki B. Importance of binaural hearing. Audiol Neurootol. 2015;20 Suppl 1:3-6. doi: 10.1159/000380741. Epub 2015 May 19. Review. — View Citation

Chole RA, McKenna M. Pathophysiology of otosclerosis. Otol Neurotol. 2001 Mar;22(2):249-57. Review. — View Citation

De Seta E, Rispoli G, Balsamo G, Covelli E, De Seta D, Filipo R. Indication for surgery in otosclerotic patients with unilateral hearing loss. Otol Neurotol. 2009 Dec;30(8):1116-21. doi: 10.1097/MAO.0b013e3181bc3c22. — View Citation

Fayad JN, Semaan MT, Meier JC, House JW. Hearing results using the SMart piston prosthesis. Otol Neurotol. 2009 Dec;30(8):1122-7. doi: 10.1097/MAO.0b013e3181be645d. — View Citation

Gartrell BC, Jones HG, Kan A, Buhr-Lawler M, Gubbels SP, Litovsky RY. Investigating long-term effects of cochlear implantation in single-sided deafness: a best practice model for longitudinal assessment of spatial hearing abilities and tinnitus handicap. Otol Neurotol. 2014 Oct;35(9):1525-32. doi: 10.1097/MAO.0000000000000437. — View Citation

Gros A, Vatovec J, Sereg-Bahar M. Histologic changes on stapedial footplate in otosclerosis. Correlations between histologic activity and clinical findings. Otol Neurotol. 2003 Jan;24(1):43-7. — View Citation

Husain Q, Lin KF, Selesnick SH. Stapes prosthesis length and hearing outcomes. Laryngoscope. 2018 Mar;128(3):722-726. doi: 10.1002/lary.26700. Epub 2017 May 31. — View Citation

Jansen S, Luts H, Wagener KC, Kollmeier B, Del Rio M, Dauman R, James C, Fraysse B, Vormès E, Frachet B, Wouters J, van Wieringen A. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol. 2012 Mar;51(3):164-73. doi: 10.3109/14992027.2011.633568. Epub 2011 Nov 28. — View Citation

Rudic M, Keogh I, Wagner R, Wilkinson E, Kiros N, Ferrary E, Sterkers O, Bozorg Grayeli A, Zarkovic K, Zarkovic N. The pathophysiology of otosclerosis: Review of current research. Hear Res. 2015 Dec;330(Pt A):51-6. doi: 10.1016/j.heares.2015.07.014. Epub 2015 Aug 12. Review. — View Citation

Schleich P, Nopp P, D'Haese P. Head shadow, squelch, and summation effects in bilateral users of the MED-EL COMBI 40/40+ cochlear implant. Ear Hear. 2004 Jun;25(3):197-204. — View Citation

Vasama JP, Linthicum FH Jr. Temporal bone histopathology case of the month: otosclerosis. Am J Otol. 1998 May;19(3):398-9. — View Citation

Veillon F, Riehm S, Emachescu B, Haba D, Roedlich MN, Greget M, Tongio J. Imaging of the windows of the temporal bone. Semin Ultrasound CT MR. 2001 Jun;22(3):271-80. Review. — View Citation

Wegner I, van Waes AM, Bittermann AJ, Buitinck SH, Dekker CF, Kurk SA, Rados M, Grolman W. A Systematic Review of the Diagnostic Value of CT Imaging in Diagnosing Otosclerosis. Otol Neurotol. 2016 Jan;37(1):9-15. doi: 10.1097/MAO.0000000000000924. Review. — View Citation

Weiss R, Leinung M, Baumann U, Weißgerber T, Rader T, Stöver T. Improvement of speech perception in quiet and in noise without decreasing localization abilities with the bone conduction device Bonebridge. Eur Arch Otorhinolaryngol. 2017 May;274(5):2107-2115. doi: 10.1007/s00405-016-4434-2. Epub 2016 Dec 28. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of squelch effect 9 months after surgery	Speech reception threshold between S0N90 situation after and before surgery	9 months
Secondary	Measure of shadow effect 9 months after surgery	Comparison of Speech reception threshold between (S0N90) - (S0N-90) between 9months after surgery and before surgery	9 months
Secondary	Measure of binaural benefit 9 months after surgery	Comparison of Speech reception threshold S0N0 between 9months after surgery and before surgery	9 months
Secondary	improving quality of life : Abbreviated Profile of Hearing Aid Benefit	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
Secondary	Improving quality of life : Speech and Spatial Questionnaire	comparison of the global score and the three sub-scale: "speech hearing"; "spatial hearing"; "qualities of hearing"	9 months
Secondary	Measure of squelch effect 3 months after surgery	Speech reception threshold between S0N90 situation after and before surgery	3 months
Secondary	Measure of binaural benefit 3 months after surgery	Comparison of Speech reception threshold S0N0 between 3 months after surgery and before surgery	3 months
Secondary	Measure of shadow effect 3 months after surgery	Comparison of Speech reception threshold between (S0N90) - (S0N-90) between 3 months after surgery and before surgery	3 months
Secondary	improving quality of life : Abbreviated Profile of Hearing Aid Benefit	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
Secondary	Improving quality of life : Speech and Spatial Questionnaire	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