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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07384091

Acronym

AA by B250

Enrollment

Registered

2026-02-03

Start date

2026-02-01

Completion date

2026-12-31

Last updated

2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autophony, Pulsatile Tinnitus, Superior Canal Dehiscence Syndrome

Keywords

SCDS, Ankle audiometry, B250

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.

Interventions

DIAGNOSTIC_TESTAnkle 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 intensity at the ankle will be 140 dB FL.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Sweden

Contacts

CONTACTLuca Verrecchia, MD PhD

luca.verrecchia@ki.se0046-724654523

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026