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NCT Number: 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

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.

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Key information

Conditions

Superior Canal Dehiscence Syndrome Autophony Ear Diseases Hearing Disorders Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pulsatile Tinnitus Semicircular Canal Dehiscence Sensation Disorders Signs and Symptoms Tinnitus Vestibular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital, Hearing and Balance Unit

Stockholm, Huddinge, 141 57, Sweden

Location contact

Luca Verrecchia, MD PhD

CONTACT

[email protected]

0046-724654523

Luca Verrecchia, MD PhD

PRINCIPAL_INVESTIGATOR

Zheer Tawfique, MD PhD student

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

Time frame: At the end of the performed ankle audiometry test.

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Verrecchia, MD PhD

CONTACT

[email protected]

0046-724654523

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Registry information

Acronym: AA by B250

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 3, 2026
Registry last updated: Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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