Electro-physiological Findings and Symptoms Severity in Superior Canal Dehiscence (INTEX-DEHI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Superior Semicircular Canal Dehiscence
• Intervention / Treatment: Diagnostic test: Wideband tympanometry; Diagnostic test: Electrocochleography; Diagnostic test: Vestibular Evoked Myogenic potentials

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 Type: Interventional
• Enrollment (Estimated): 115
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yohan Gallois, Dr; Phone Number: +33 05-61-77-77-04; Email: gallois.y@chu-toulouse.fr
• Study Contact Backup: Name: Mathieu MARX, Pr; Email: marx.m@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Interventional; Electrophysiological tests	Diagnostic test: Wideband tympanometry; Wideband tympanometry; Diagnostic test: Electrocochleography; Electrocochleography; Diagnostic test: Vestibular Evoked Myogenic potentials; Vestibular Evoked Myogenic potentials

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Yohan GALLOIS, Dr, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pulsatile tinnitus; Superior semi-circular canal dehiscence; Autophony Tullio phenomenon; Minor syndrome
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Semicircular Canal Dehiscence
• Other Study ID Numbers: RC31/22/0322; 2023-A01856-39 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No