Electro-physiological Findings and Symptoms Severity in Superior Canal Dehiscence

Superior Semicircular Canal Dehiscence Clinical Trial

— INTEX-DEHI  

Official title:

Interest of Electro-physiological Findings in the Assessment of Symptoms Severity in Superior Semi-circular Canal Dehiscence Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06170398
• Other study ID #: RC31/22/0322
• Secondary ID: 2023-A01856-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: January 2026

Study information

• Verified date: December 2023
• Source: University Hospital, Toulouse
• Contact: Yohan Gallois, Dr
• Phone: 05-61-77-77-04
• Email: gallois.y[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 115
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Superior Semicircular Canal Dehiscence

Intervention

Diagnostic Test:
• Wideband tympanometry
Wideband tympanometry
• Electrocochleography
Electrocochleography
• Vestibular Evoked Myogenic potentials
Vestibular Evoked Myogenic potentials

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	30 day
Primary	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)	30 day
Primary	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)	30 day
Primary	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)	30 day