Electro-physiological Findings and Symptoms Severity in Superior Canal Dehiscence

NCT ID: NCT06170398

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2026-01-31

Brief Summary

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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

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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

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Superior Semicircular Canal Dehiscence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Interventional

Electrophysiological tests

Group Type OTHER

Wideband tympanometry

Intervention Type DIAGNOSTIC_TEST

Wideband tympanometry

Electrocochleography

Intervention Type DIAGNOSTIC_TEST

Electrocochleography

Vestibular Evoked Myogenic potentials

Intervention Type DIAGNOSTIC_TEST

Vestibular Evoked Myogenic potentials

Interventions

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Wideband tympanometry

Wideband tympanometry

Intervention Type DIAGNOSTIC_TEST

Electrocochleography

Electrocochleography

Intervention Type DIAGNOSTIC_TEST

Vestibular Evoked Myogenic potentials

Vestibular Evoked Myogenic potentials

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* bilateral confirmed SCD
* doubtful SCD
* other otologic or neurotologic condition that might mimick SCD symptomatology : middle ear conditions, Meniere disease, vestibular migraine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yohan GALLOIS, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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CHU Toulouse

Toulouse, , France

Site Status

Countries

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France

Central Contacts

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Yohan Gallois, Dr

Role: CONTACT

05-61-77-77-04 ext. +33

Mathieu MARX, Pr

Role: CONTACT

References

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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.

Reference Type DERIVED
PMID: 40966240 (View on PubMed)

Other Identifiers

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2023-A01856-39

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/22/0322

Identifier Type: -

Identifier Source: org_study_id

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