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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The detection of SCDS among patients with autophony and/or pulsatile tinnitus. | At the end of the performed ankle audiometry test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Verrecchia, MD PhD | Contact | 0046-724654523 | luca.verrecchia@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital, Hearing and Balance Unit | Stockholm | Huddinge | 141 57 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33522990 | Background | 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. | |
| 36634643 |
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|
| 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. |
| 10680810 | 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. |
| ID | Term |
|---|---|
| D000084322 | Semicircular Canal Dehiscence |
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006311 | Hearing Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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