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Not yet recruitingNCT07384091AA by B250Updated Feb 3, 2026

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

An interventional study of Ankle audiometry performed with the B250 transducer in Superior Canal Dehiscence Syndrome, Autophony and Pulsatile Tinnitus, sponsored by Region Stockholm. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Region Stockholm · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Superior Canal Dehiscence Syndrome
  • Autophony
  • Pulsatile Tinnitus

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Keywords

  • SCDS
  • Ankle audiometry
  • B250
03

In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's planned enrollment of 30 is below the median of 60 across 368 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

Region Stockholm is the lead sponsor of 121 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Severe sensorineural hearing.
  • Middle ear or ear canal pathologies.
  • Vulnerable patients.
  • Confirmed intolerance or for body (ankle) vibratory stimulation.
  • Anatomical body anomalies affecting normal testing procedure or interpretation of results.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Ankle audiometry testing with B250

    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

    Diagnostic Test: Ankle audiometry performed with the B250 transducer

Interventions

  • Diagnostic testAnkle audiometry performed with the B250 transducer

    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.

06

What researchers measure

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.

07

Study locations

1 site
  • Karolinska University Hospital, Hearing and Balance Unit
    Stockholm, Huddinge 141 57, Sweden
    • Luca Verrecchia, MD PhD · Contactluca.verrecchia@ki.se · 0046-724654523
    • Luca Verrecchia, MD PhD · Principal investigator
    • Zheer Tawfique, MD PhD student · Principal investigator
08

References and documents

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 33522990 ↗
  • 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. PubMed 36634643 ↗
  • 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. PubMed 10680810 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2026; primary completion for Dec 2026, 10 months later.

Of 133 non-industry interventional studies with no phase under Tinnitus, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 10 months is below that.

Counting every sponsor, half of 151 studies reached it within 17 months; a quarter within 10 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2026
First posted
Feb 3, 2026
StartEst.
Feb 1, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Feb 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07384091
Lead sponsor
Region Stockholm
Responsible party
Luca Verrecchia (Principal investigator, Region Stockholm) — Principal investigator
First posted
Feb 3, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 3, 2026

Study contacts

Luca Verrecchia, MD PhD
Contact
luca.verrecchia@ki.se
0046-724654523

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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