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Not yet recruiting NCT07384091

The Diagnostic Accuracy of Ankle Audiometry Performed With the B250 for Superior Canal Dehiscence Syndrome in Patients Affected by Pulsatile Tinnitus and/or Autophony Disorders

No phase Interventional Superior Canal Dehiscence Syndrome Autophony Pulsatile Tinnitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ankle audiometry performed with the B250 transducer.
Who it may be relevant to
Registry conditions: Superior Canal Dehiscence Syndrome, Autophony, Pulsatile Tinnitus. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The goal of this clinical trial is to learn if the ankle audiometry test performed with the B250 bone conduction transducer can identify patients with superior canal dehiscence syndrome from those without among subjects presenting with autophony (a hearing condition where you hear your own body sounds) and/or pulsatile tinnitus. The main question it aims to answer: • Can ankle audiometry performed with B250 identify the condition of superior canal dehiscence syndrome among patients with autophony and/or pulsatile tinnitus, with a significance level of 80% and power level of 15%? Study participants will undergo ankle audiometry testing with the B250 and the threshold in dB FL (at the ankle) for which the patient hears the sound in the target ear will be measured.

Interventions

  • Diagnostic test Ankle audiometry performed with the B250 transducer
    Calibrated vibration stimulation with a frequency of 250 Hz is applied at the ankle with the B250 transducer starting at an intensity of 80 dB FL. An incremental increase/decrease in the intensity of the applied bone vibration stimulus is employed in a manner similar to that performed during a standard pure tone hearing test. This is done in order to find the threshold in dB FL (at the ankle) for which the patient hears the sound in the target ear (right) is measured. The maximum applied intensi

Primary outcome measures

  • The detection of SCDS among patients with autophony and/or pulsatile tinnitus. [Time frame: At the end of the performed ankle audiometry test.]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 64 years.
  • Patients with symptoms of autophony and/or pulsatile tinnitus either due to a confirmed diagnosis of SCDS or not due to SCDS.

Exclusion criteria

  • Severe sensorineural hearing.
  • Middle ear or ear canal pathologies.
  • Vulnerable patients.
  • Confirmed intolerance or contraindication for body (ankle) vibratory stimulation.
  • Anatomical body anomalies affecting normal testing procedure or interpretation of results.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Sweden · 1 center
  • Karolinska University Hospital, Hearing and Balance Unit — Stockholm

Publications

  • Ward BK, van de Berg R, van Rompaey V, Bisdorff A, Hullar TE, Welgampola MS, Carey JP. Superior semicircular canal dehiscence syndrome: Diagnostic criteria consensus document of the committee for the classification of vestibular disorders of the Barany Society. J Vestib Res. 2021;31(3):131-141. doi: 10.3233/VES-200004. PMID 33522990
  • Verrecchia L, Freden Jansson KJ, Westin M, Velikoselskii A, Reinfeldt S, Hakansson B. Ankle Audiometry: A Clinical Test for the Enhanced Hearing Sensitivity for Body Sounds in Superior Canal Dehiscence Syndrome. Audiol Neurootol. 2023;28(3):219-229. doi: 10.1159/000528407. Epub 2023 Jan 12. PMID 36634643
  • Watson SR, Halmagyi GM, Colebatch JG. Vestibular hypersensitivity to sound (Tullio phenomenon): structural and functional assessment. Neurology. 2000 Feb 8;54(3):722-8. doi: 10.1212/wnl.54.3.722. PMID 10680810

Identifiers

NCT: NCT07384091 · 2025-7292

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗