Superior Semicircular Canal DehiscenceINTEX-DEHINCT06170398
Electro-physiological Findings and Symptoms Severity in Superior Canal Dehiscence
A study testing Wideband tympanometry, Electrocochleography and Vestibular Evoked Myogenic potentials in people with Superior Semicircular Canal Dehiscence, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This research aims at assessing the validity of three different electro-physiological tests (Vestibular Evoked Myogenic Potentials, WideBand Tympanometry, Electrocochleography) used in the investigation of the symptoms severity in the case of superior semi-circular canal dehiscence syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superior Semicircular Canal Dehiscence
- What is being tested?
- Wideband tympanometry, Electrocochleography and Vestibular Evoked Myogenic potentials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2024to Jan 2026
- Phase
- Interventional
- 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
Who may be able to join
- confirmed unilateral SCD (using specific HRCT settings and reconstructions) with or without SCD symptoms
- if present, SCD symptoms should be stable
- patients understanding and reading french
- affiliated to social security.
Who cannot join
- bilateral confirmed SCD
- doubtful SCD
- other otologic or neurotologic condition that might mimick SCD symptomatology : middle ear conditions, Meniere disease, vestibular migraine
Trial locations and contacts
1 site in 1 country.
Mathieu MARX, Pr contact
About this study
Official title: Interest of Electro-physiological Findings in the Assessment of Symptoms Severity in Superior Semi-circular Canal Dehiscence Syndrome
This research aims at assessing the validity of three different electro-physiological tests (Vestibular Evoked Myogenic Potentials, WideBand Tympanometry, Electrocochleography) used in the investigation of the symptoms severity in the case of superior semi-circular canal dehiscence syndrome.
Read the detailed description
Superior semi-circular canal dehiscence (SCD) syndrome can associate several cochlear and vestibular symptoms. Recent systematic reviews identified pulsatile tinnitus, autophony, sound-induced and pressure-induced vertigo as most specific signs of SCD. These signs are rarely all present and the symptomatology remains highly variable from a patient to another, with frequent though less evocative symptoms such as dizziness or ear pressure. A surgical treatment may be proposed when the symptoms become significantly incapacitating. Unfortunately to date, there is no objective marker of this severity and all surgical decisions rely on the importance of patients' complaints. High Resolution Computed Tomography (HRCT) of the temporal bone can confirm the diagnosis. Electro-physiological investigations such as Vestibular Evoked Myogenic potentials (VEMPs) have also been extensively described in the diagnosis of SCD but they have been reported as independent from the symptoms severity. Wideband tympanometry (WBT) and Electrocochleography (EcoG) have only been studied in few reports but the latter appears as a promising tool in the assessment of the symptoms because it explores inner ear biomechanics, directly involved in the pathophysiology of this condition.
- Conditions
- Superior Semicircular Canal Dehiscence
- Being tested
- Wideband tympanometry, Electrocochleography, Vestibular Evoked Myogenic potentials
- Keywords
- Superior semi-circular canal dehiscence, Minor syndrome, Pulsatile tinnitus, Autophony Tullio phenomenon
- Medical subject headings
- Semicircular Canal Dehiscence, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wideband tympanometryDiagnostic test
Wideband tympanometry
ElectrocochleographyDiagnostic test
Electrocochleography
Vestibular Evoked Myogenic potentialsDiagnostic test
Vestibular Evoked Myogenic potentials
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Other | Electrophysiological tests Receives: Diagnostic Test: Wideband tympanometry; Diagnostic Test: Electrocochleography; Diagnostic Test: Vestibular Evoked Myogenic potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
EcoG validity - pulsatile tinnitus
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (pulsatile tinnitus) assessed by a visual analogue scale (0 to 10)
Measured: 30 day
EcoG validity - autophony
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (autophony) assessed by a visual analogue scale (0 to 10)
Measured: 30 day
EcoG validity - dizziness induced by loud sounds
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (dizziness induced by loud sounds) assessed by a visual analogue scale (0 to 10)
Measured: 30 day
EcoG validity - dizziness induced by pressure changes
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (dizziness induced by pressure changes) assessed by a visual analogue scale (0 to 10)
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Superior Semicircular Canal DehiscenceStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yohan GALLOIS, Dr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170398
- Sponsor's protocol ID
- RC31/22/0322
- Other IDs
- 2023-A01856-39
- Acronym
- INTEX-DEHI
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Legois Q, Giraudet F, Gallois Y, Lepage B, Ionescu E, Vellin JF, Franco-Vidal V, Kaderbay A, Vellin MJ; French Association of Superior Semicircular Canal Dehiscence syndrome; Marx M. INTerest of electrophysiological and functional EXploration in the evaluation of symptomatic impact of superior semicircular canal DEHIscence syndrome (INTEX-DEHI study): Study protocol for a reliability and validity study. PLoS One. 2025 Sep 18;20(9):e0331763. doi: 10.1371/journal.pone.0331763. eCollection 2025.
PubMed 40966240
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Electro-physiological Findings in the Assessment of Symptoms Severity in Superior Semi-circular Canal Dehiscence Syndrome
- ClinicalTrials.gov ID
- NCT06170398
- Acronym / sponsor ID
- INTEX-DEHI / RC31/22/0322
- Conditions
- Superior Semicircular Canal Dehiscence
- Keywords
- Superior semi-circular canal dehiscence, Minor syndrome, Pulsatile tinnitus, Autophony Tullio phenomenon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Dec 2023 (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.
This research aims at assessing the validity of three different electro-physiological tests (Vestibular Evoked Myogenic Potentials, WideBand Tympanometry, Electrocochleography) used in the investigation of the symptoms severity in the case of superior semi-circular canal dehiscence syndrome.
Detailed description
Superior semi-circular canal dehiscence (SCD) syndrome can associate several cochlear and vestibular symptoms. Recent systematic reviews identified pulsatile tinnitus, autophony, sound-induced and pressure-induced vertigo as most specific signs of SCD. These signs are rarely all present and the symptomatology remains highly variable from a patient to another, with frequent though less evocative symptoms such as dizziness or ear pressure. A surgical treatment may be proposed when the symptoms become significantly incapacitating. Unfortunately to date, there is no objective marker of this severity and all surgical decisions rely on the importance of patients' complaints. High Resolution Computed Tomography (HRCT) of the temporal bone can confirm the diagnosis. Electro-physiological investigations such as Vestibular Evoked Myogenic potentials (VEMPs) have also been extensively described in the diagnosis of SCD but they have been reported as independent from the symptoms severity. Wideband tympanometry (WBT) and Electrocochleography (EcoG) have only been studied in few reports but the latter appears as a promising tool in the assessment of the symptoms because it explores inner ear biomechanics, directly involved in the pathophysiology of this condition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Other | Diagnostic Test: Wideband tympanometry, Diagnostic Test: Electrocochleography, Diagnostic Test: Vestibular Evoked Myogenic potentialsElectrophysiological tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- confirmed unilateral SCD (using specific HRCT settings and reconstructions) with or without SCD symptoms
- if present, SCD symptoms should be stable
- patients understanding and reading french
- affiliated to social security.
Key exclusion criteria (3 listed)
- bilateral confirmed SCD
- doubtful SCD
- other otologic or neurotologic condition that might mimick SCD symptomatology : middle ear conditions, Meniere disease, vestibular migraine
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 |
|---|---|---|
| Wideband tympanometryWideband tympanometry | Diagnostic test | Interventional |
| ElectrocochleographyElectrocochleography | Diagnostic test | Interventional |
| Vestibular Evoked Myogenic potentialsVestibular Evoked Myogenic potentials | Diagnostic test | Interventional |
Primary outcome
EcoG validity - pulsatile tinnitus
Time frame: 30 day
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (pulsatile tinnitus) assessed by a visual analogue scale (0 to 10)
EcoG validity - autophony
Time frame: 30 day
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (autophony) assessed by a visual analogue scale (0 to 10)
EcoG validity - dizziness induced by loud sounds
Time frame: 30 day
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (dizziness induced by loud sounds) assessed by a visual analogue scale (0 to 10)
EcoG validity - dizziness induced by pressure changes
Time frame: 30 day
the validity of EcoG will be assessed by the correlation between the alteration of the summating potential/action potential ratio and symptom severity (dizziness induced by pressure changes) assessed by a visual analogue scale (0 to 10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Derived from this study: PubMed 40966240Legois Q, Giraudet F, Gallois Y, Lepage B, Ionescu E, Vellin JF, Franco-Vidal V, Kaderbay A, Vellin MJ; French Association of Superior Semicircular Canal Dehiscence syndrome; Marx M. INTerest of electrophysiological and functional EXploration in the evaluation of symptomatic impact of superior semicircular canal DEHIscence syndrome (INTEX-DEHI study): Study protocol for a reliability and validity study. PLoS One. 2025 Sep 18;20(9):e0331763. doi: 10.1371/journal.pone.0331763. eCollection 2025.
- Individual participant dataSharing planned: No
Related trials for Superior Semicircular Canal Dehiscence
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruiting
The Diagnostic Accuracy of Ankle Audiometry Performed With the B250 for Superior Canal Dehiscence Syndrome in Patients Affected by Pulsatile Tinnitus and/or Autophony Disorders
Superior Canal Dehiscence Syndrome, Autophony
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.
Mathieu MARX, Pr contact
Yohan GALLOIS, Dr principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wideband tympanometry, Electrocochleography and Vestibular Evoked Myogenic potentials in people with Superior Semicircular Canal Dehiscence, run by University Hospital, Toulouse 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 4 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yohan Gallois, Dr (05-61-77-77-04 ext. +33, gallois.y@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EcoG validity - pulsatile tinnitus (time frame: 30 day). The study lists 4 primary outcomes in all. 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 NCT06170398, which also lists 1 linked publication.
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 20 Dec 2023.