NCT06170398

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

2 years

First QC Date

December 6, 2023

Last Update Submit

December 13, 2023

Conditions

Superior Semicircular Canal Dehiscence

Keywords

Superior semi-circular canal dehiscenceMinor syndromePulsatile tinnitusAutophony Tullio phenomenon

Outcome Measures

Primary Outcomes (4)

  • 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 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

  • 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

Study Arms (1)

Interventional

OTHER

Electrophysiological tests

Diagnostic Test: Wideband tympanometryDiagnostic Test: ElectrocochleographyDiagnostic Test: Vestibular Evoked Myogenic potentials

Interventions

Wideband tympanometryDIAGNOSTIC_TEST

Wideband tympanometry

Interventional
ElectrocochleographyDIAGNOSTIC_TEST

Electrocochleography

Interventional
Vestibular Evoked Myogenic potentialsDIAGNOSTIC_TEST

Vestibular Evoked Myogenic potentials

Interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • bilateral confirmed SCD
  • doubtful SCD
  • other otologic or neurotologic condition that might mimick SCD symptomatology : middle ear conditions, Meniere disease, vestibular migraine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, 31059, France

Location

Related Publications (1)

  • Legois Q, Giraudet F, Gallois Y, Lepage B, Ionescu E, Vellin JF, Franco-Vidal V, Kaderbay A, Vellin MJ; French Association of Superior Semicircular Canal Dehiscence syndrome; Marx M. INTerest of electrophysiological and functional EXploration in the evaluation of symptomatic impact of superior semicircular canal DEHIscence syndrome (INTEX-DEHI study): Study protocol for a reliability and validity study. PLoS One. 2025 Sep 18;20(9):e0331763. doi: 10.1371/journal.pone.0331763. eCollection 2025.

    PMID: 40966240DERIVED

MeSH Terms

Conditions

Semicircular Canal DehiscenceTinnitus

Interventions

Audiometry, Evoked ResponseVestibular Evoked Myogenic Potentials

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesHearing DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AudiometryHearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosisEvoked Potentials, MotorEvoked PotentialsCortical ExcitabilityElectrophysiological PhenomenaPhysiological Phenomena

Study Officials

  • Yohan GALLOIS, Dr

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yohan Gallois, Dr

CONTACT

05-61-77-77-04gallois.y@chu-toulouse.fr

Mathieu MARX, Pr

CONTACT

marx.m@chu-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

January 1, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

December 20, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)