Clinical trial NCT06170398: Electro-physiological Findings and Symptoms Severity in Superior Canal Dehiscence
Official title: Interest of Electro-physiological Findings in the Assessment of Symptoms Severity in Superior Semi-circular Canal Dehiscence Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Superior Semicircular Canal Dehiscence
Keywords: Superior semi-circular canal dehiscence
Minor syndrome
Pulsatile tinnitus
Autophony Tullio phenomenon
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: EcoG validity - pulsatile tinnitus
timeFrame: 30 day
measure: EcoG validity - autophony
timeFrame: 30 day
measure: EcoG validity - dizziness induced by loud sounds
timeFrame: 30 day
measure: EcoG validity - dizziness induced by pressure changes
timeFrame: 30 day
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Yohan GALLOIS, Dr
role: PRINCIPAL_INVESTIGATOR
References: