Superior Canal Dehiscence SyndromeAA by B250NCT07384091
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
A study testing Ankle audiometry performed with the B250 transducer in people with Superior Canal Dehiscence Syndrome and Autophony, run by Region Stockholm at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Superior Canal Dehiscence Syndrome, Autophony, Pulsatile Tinnitus
- What is being tested?
- Ankle audiometry performed with the B250 transducer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Karolinska University Hospital, Hearing and Balance Unit
Stockholm, Huddinge, 141 57
Luca Verrecchia, MD PhD, 0046-724654523, luca.verrecchia@ki.se
Luca Verrecchia, MD PhD
About this study
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:
Read more
- 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.
- Being tested
- Ankle audiometry performed with the B250 transducer
- Keywords
- SCDS, Ankle audiometry, B250
- Medical subject headings
- Semicircular Canal Dehiscence, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle audiometry performed with the B250 transducerDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Ankle audiometry performed with the B250 transducer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection of SCDS among patients with autophony and/or pulsatile tinnitus.
Measured: At the end of the performed ankle audiometry test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Superior Canal Dehiscence SyndromeStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Luca Verrecchia, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384091
- Sponsor's protocol ID
- 2025-7292
- Acronym
- AA by B250
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33522990Verrecchia 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.
PubMed 36634643Watson 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.
PubMed 10680810
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07384091
- Acronym / sponsor ID
- AA by B250 / 2025-7292
- Keywords
- SCDS, Ankle audiometry, B250
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ankle audiometry testing with B250 | Experimental | Diagnostic Test: Ankle audiometry performed with the B250 transducerThe 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle audiometry performed with the B250 transducerCalibrated 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. | Diagnostic test | Ankle audiometry testing with B250 |
Primary outcome
The detection of SCDS among patients with autophony and/or pulsatile tinnitus.
Time frame: At the end of the performed ankle audiometry test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 33522990Ward 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.
- Background: PubMed 36634643Verrecchia 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.
- Background: PubMed 10680810Watson 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.
- Individual participant dataSharing planned: No
Related trials for Superior Canal Dehiscence Syndrome
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle audiometry performed with the B250 transducer in people with Superior Canal Dehiscence Syndrome and Autophony, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Verrecchia, MD PhD (0046-724654523, luca.verrecchia@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection of SCDS among patients with autophony and/or pulsatile tinnitus. (time frame: At the end of the performed ankle audiometry test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07384091, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.