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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorRegion Stockholm

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Severe sensorineural hearing.

Middle ear or ear canal pathologies.

Vulnerable patients.

Confirmed intolerance or contraindication for body (ankle) vibratory stimulation.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Ankle audiometry testing with B250Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: