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 (AA by B250)

Region Stockholm

Status: Not yet enrolling

Conditions: Superior Canal Dehiscence Syndrome; Pulsatile Tinnitus; Autophony

Treatments: Diagnostic Test: Ankle audiometry performed with the B250 transducer

Study type: Interventional

Funder types: Other

Identifiers

NCT07384091

2025-7292

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Ankle audiometry testing with B250

Experimental group

Description:

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

Treatment:

Diagnostic Test: Ankle audiometry performed with the B250 transducer