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

T

Toulouse University Hospital

Status

Not yet enrolling

Conditions

Superior Semicircular Canal Dehiscence

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06170398
RC31/22/0322
2023-A01856-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

115 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

115 participants in 1 patient group

Interventional
Other group
Description:
Electrophysiological tests
Treatment:
Diagnostic Test: Electrocochleography
Diagnostic Test: Vestibular Evoked Myogenic potentials
Diagnostic Test: Wideband tympanometry

Trial contacts and locations

1

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Central trial contact

Mathieu MARX, Pr; Yohan Gallois, Dr

Data sourced from clinicaltrials.gov

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