Electro-physiological Findings and Symptoms Severity in Superior Canal Dehiscence

Not Applicable

Not yet recruiting

• Conditions: Superior Semicircular Canal Dehiscence
• Interventions: Diagnostic Test: Wideband tympanometry; Diagnostic Test: Electrocochleography; Diagnostic Test: Vestibular Evoked Myogenic potentials

• Registration Number: NCT06170398
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

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 Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-14
• Last Update Posted: 2023-12-20
• Study Start: 2024-01
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	Wideband tympanometry	Electrophysiological tests
Interventional	Vestibular Evoked Myogenic potentials	Electrophysiological tests
Interventional	Electrocochleography	Electrophysiological tests

Primary Outcome Measures

Name	Time	Method
EcoG validity - pulsatile tinnitus	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	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	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	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)

Trial Locations

Locations (1)

CHU Toulouse; 🇫🇷 Toulouse, France