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

NCT07384091 | Not Yet Recruiting

• 1 other identifier: 2025-7292
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Superior Canal Dehiscence Syndrome; Autophony; Pulsatile Tinnitus

Keywords

SCDS; Ankle audiometry; B250

Outcome Measures

Primary Outcomes (1)

• The detection of SCDS among patients with autophony and/or pulsatile tinnitus.

  At the end of the performed ankle audiometry test.

Study Arms (1)

Ankle audiometry testing with B250

EXPERIMENTAL

The arm consist of 30 consecutive adults (18-64 years) with autophony and/or pulsatile tinnitus, of which at least 15 are affected by superior canal dehiscense syndrome. All subjects will undergo testing with ankle audiometry (intervention) according to the method described in PMID: 36634643

Diagnostic Test: Ankle audiometry performed with the B250 transducer

Interventions

Ankle audiometry performed with the B250 transducer DIAGNOSTIC_TEST

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 intensity at the ankle will be 140 dB FL.

Ankle audiometry testing with B250

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Karolinska University Hospital, Hearing and Balance Unit

Stockholm, Huddinge, 141 57, Sweden

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Semicircular Canal Dehiscence; Tinnitus

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Luca Verrecchia, MD PhD

CONTACT

0046-724654523; luca.verrecchia@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)