Otosclerosis of Middle EarCBOUNCT03587792
Study of Binaural Squelch Effect in Unilateral Otosclerosis
An observational study of Otosclerosis of Middle Ear and Unilateral Hearing Loss, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Otosclerosis of Middle Ear, Unilateral Hearing Loss
- What is being tested?
- stapedectomy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2018to 11 Dec 2019
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients undergoing a stapedectomy for unilateral disabled ear due to otosclerosis
Who may be able to join
- diagnosis of otosclerosis
- controlateral audiometry under 30dB loss
- the ear to be operated with a transmission over 30dB
Who cannot join
- otosclerosis which has already operated on the ear studied
- other cause of transmission hypoacusis
- transmission after surgery other 30dB
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Grenoble
Grenoble, Rhone Alpes Auvergne, 38000
About this study
Official title: 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.
Read the 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.
- Being tested
- stapedectomy
- Medical subject headings
- Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stapedectomyProcedure or surgery
Also called platinectomy
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of squelch effect 9 months after surgery
Speech reception threshold between S0N90 situation after and before surgery
Measured: 9 months
Secondary outcomes (9)
Measure of shadow effect 9 months after surgery
Comparison of Speech reception threshold between (S0N90) - (S0N-90) between 9months after surgery and before surgery
Measured: 9 months
Measure of binaural benefit 9 months after surgery
Comparison of Speech reception threshold S0N0 between 9months after surgery and before surgery
Measured: 9 months
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
Measured: 9 months
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"
Measured: 9 months
Measure of squelch effect 3 months after surgery
Speech reception threshold between S0N90 situation after and before surgery
Measured: 3 months
Measure of binaural benefit 3 months after surgery
Comparison of Speech reception threshold S0N0 between 3 months after surgery and before surgery
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start6 Mar 2018
- Primary completion11 Dec 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Otosclerosis of Middle EarStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03587792
- Sponsor's protocol ID
- 38RC17.325
- Other IDs
- 2017-A02900-53
- Acronym
- CBOU
- Status last verified
- Feb 2020
- First submitted
- 4 Jun 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26276418Vasama JP, Linthicum FH Jr. Temporal bone histopathology case of the month: otosclerosis. Am J Otol. 1998 May;19(3):398-9. No abstract available.
PubMed 9596194Veillon 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.
PubMed 11451100Chole RA, McKenna M. Pathophysiology of otosclerosis. Otol Neurotol. 2001 Mar;22(2):249-57. doi: 10.1097/00129492-200103000-00023.
PubMed 11300278Wegner 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.
PubMed 26649602Gros 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.
PubMed 12544027Husain 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.
PubMed 28561306Fayad 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.
PubMed 19816231Avan 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.
PubMed 25998698Weiss 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.
PubMed 28032241Gartrell 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.
PubMed 25158615Schleich 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.
PubMed 15179111Jansen 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.
PubMed 22122354De 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.
PubMed 19752765Baguant 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.
PubMed 33846850
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Binaural Squelch Effect Among Patients Undergoing Unilateral Otosclerosis Surgery: Comparison of Understanding in Noise Before-after Surgery
- ClinicalTrials.gov ID
- NCT03587792
- Acronym / sponsor ID
- CBOU / 38RC17.325
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 16 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients undergoing a stapedectomy for unilateral disabled ear due to otosclerosis
Key inclusion criteria (3 listed)
- diagnosis of otosclerosis
- controlateral audiometry under 30dB loss
- the ear to be operated with a transmission over 30dB
Key exclusion criteria (3 listed)
- otosclerosis which has already operated on the ear studied
- other cause of transmission hypoacusis
- transmission after surgery other 30dB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stapedectomyAlso: platinectomyStapedectomy 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 | Procedure or surgery | – |
Primary outcome
Measure of squelch effect 9 months after surgery
Time frame: 9 months
Speech reception threshold between S0N90 situation after and before surgery
9 secondary outcomes
Measure of shadow effect 9 months after surgery
Time frame: 9 months
Measure of binaural benefit 9 months after surgery
Time frame: 9 months
improving quality of life : Abbreviated Profile of Hearing Aid Benefit
Time frame: 9 months
Improving quality of life : Speech and Spatial Questionnaire
Time frame: 9 months
Measure of squelch effect 3 months after surgery
Time frame: 3 months
Measure of binaural benefit 3 months after surgery
Time frame: 3 months
Measure of shadow effect 3 months after surgery
Time frame: 3 months
improving quality of life : Abbreviated Profile of Hearing Aid Benefit
Time frame: 3 months
Improving quality of life : Speech and Spatial Questionnaire
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Background: PubMed 26276418Rudic 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.
- Background: PubMed 9596194Vasama JP, Linthicum FH Jr. Temporal bone histopathology case of the month: otosclerosis. Am J Otol. 1998 May;19(3):398-9. No abstract available.
- Background: PubMed 11451100Veillon 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.
- Background: PubMed 11300278Chole RA, McKenna M. Pathophysiology of otosclerosis. Otol Neurotol. 2001 Mar;22(2):249-57. doi: 10.1097/00129492-200103000-00023.
- Background: PubMed 26649602Wegner 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.
- Background: PubMed 12544027Gros 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.
- Background: PubMed 28561306Husain 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.
- Background: PubMed 19816231Fayad 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.
- Background: PubMed 25998698Avan 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.
- Background: PubMed 28032241Weiss 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.
- Background: PubMed 25158615Gartrell 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.
- Background: PubMed 15179111Schleich 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.
- Individual participant dataSharing planned: Undecided
Related trials for Otosclerosis of Middle Ear
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otosclerosis of Middle Ear and Unilateral Hearing Loss, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of squelch effect 9 months after surgery (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03587792, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.