NCT03587792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

June 4, 2018

Last Update Submit

February 24, 2020

Conditions

Otosclerosis of Middle EarUnilateral Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Measure of squelch effect 9 months after surgery

    Speech reception threshold between S0N90 situation after and before surgery

    9 months

Secondary Outcomes (9)

  • Measure of shadow effect 9 months after surgery

    9 months

  • Measure of binaural benefit 9 months after surgery

    9 months

  • improving quality of life : Abbreviated Profile of Hearing Aid Benefit

    9 months

  • Improving quality of life : Speech and Spatial Questionnaire

    9 months

  • Measure of squelch effect 3 months after surgery

    3 months

  • +4 more secondary outcomes

Interventions

stapedectomyPROCEDURE

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

Also known as: platinectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • diagnosis of otosclerosis
  • controlateral audiometry under 30dB loss
  • the ear to be operated with a transmission over 30dB

You may not qualify if:

  • otosclerosis which has already operated on the ear studied
  • other cause of transmission hypoacusis
  • transmission after surgery other 30dB

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, Rhone Alpes Auvergne, 38000, France

Location

Related Publications (15)

  • 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.

    PMID: 26276418BACKGROUND

  • Vasama JP, Linthicum FH Jr. Temporal bone histopathology case of the month: otosclerosis. Am J Otol. 1998 May;19(3):398-9. No abstract available.

    PMID: 9596194BACKGROUND

  • 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. doi: 10.1016/s0887-2171(01)90011-3.

    PMID: 11451100BACKGROUND

  • Chole RA, McKenna M. Pathophysiology of otosclerosis. Otol Neurotol. 2001 Mar;22(2):249-57. doi: 10.1097/00129492-200103000-00023.

    PMID: 11300278BACKGROUND

  • 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.

    PMID: 26649602BACKGROUND

  • 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. doi: 10.1097/00129492-200301000-00010.

    PMID: 12544027BACKGROUND

  • 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.

    PMID: 28561306BACKGROUND

  • 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.

    PMID: 19816231BACKGROUND

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

    PMID: 25998698BACKGROUND

  • Weiss R, Leinung M, Baumann U, Weissgerber T, Rader T, Stover 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.

    PMID: 28032241BACKGROUND

  • 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.

    PMID: 25158615BACKGROUND

  • 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. doi: 10.1097/01.aud.0000130792.43315.97.

    PMID: 15179111BACKGROUND

  • Jansen S, Luts H, Wagener KC, Kollmeier B, Del Rio M, Dauman R, James C, Fraysse B, Vormes 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.

    PMID: 22122354BACKGROUND

  • 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.

    PMID: 19752765BACKGROUND

  • Baguant A, Schmerber S, Baguant K, Quatre R. Binaural squelch effect in unilateral otosclerosis surgery: comparison of speech intelligibility in noise before-after surgery. Eur Arch Otorhinolaryngol. 2022 Mar;279(3):1301-1310. doi: 10.1007/s00405-021-06797-3. Epub 2021 Apr 12.

    PMID: 33846850DERIVED

MeSH Terms

Conditions

Hearing Loss, Unilateral

Interventions

Stapes Surgery

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Otologic Surgical ProceduresOtorhinolaryngologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2018

First Posted

July 16, 2018

Study Start

March 6, 2018

Primary Completion

December 11, 2019

Study Completion

December 11, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

FR(1)