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Clinical Trials/NCT06170398
NCT06170398
Not yet recruiting
Not Applicable

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

University Hospital, Toulouse1 site in 1 country115 target enrollmentJanuary 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Superior Semicircular Canal Dehiscence
Sponsor
University Hospital, Toulouse
Enrollment
115
Locations
1
Primary Endpoint
EcoG validity - pulsatile tinnitus
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2024
End Date
January 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Study Sites (1)

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