The Accuracy of Sonotubometry to Assess the Eustachian Tube

• Research type

  Research Study

• Full title

  Assessing the Sensitivity and Specificity of Sonotubometry to Measure the Eustachian Tube Function

• IRAS ID

  324443

• Contact name

  Tobia Sebastiano Nava

• Contact email

  tsn23@cam.ac.uk

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

• Clinicaltrials.gov Identifier

  NCT05740384

• Duration of Study in the UK

  0 years, 5 months, 30 days

• Research summary

  The Eustachian tube (ET) connects the middle ear with the throat and is important for maintaining a healthy middle ear. Sonotubometry is a new method to measure how well the ET works by using sound. A speaker is placed at the nostril and a microphone records sound in the external ear canal. The ET is closed at rest and opens with swallowing. This is measured as an increase in sound measured in the external ear by sonotubometry.

  Previous research has not proven that sonotubometry is reliable enough to be used in clinics to assess ET dysfunction (a disease where the ET does not open properly). In a recent study with healthy volunteers, it was possible to identify many of the existing issues of sonotubometry and improve the reliability of this method. This was primarily achieved by testing different sound types and sound volumes. This study aims to assess the reliability and usability of the new testing protocol in study participants with ET dysfunction. The results of this study will then be compared with the results from the previous study with healthy volunteers to work out how well sonotubometry works. Ultimately, this research aims to improve the ability to diagnose ET dysfunction.

  Lay Summary of Results

  This research aimed to improve our understanding of sonotubometry, a method used to assess how well the Eustachian tube (which connected the ear to the back of the nose) works Three distinct 'noise sources' were found: sound leakage from the speaker, a clicking noise at the start of ET opening, and rumbling/swallowing noise. We found that noise occurring during sonotubometry can be easily misunderstood as opening of the ET. This will help us analyse sonotubometry results in the future.

  Has the registry been updated to include summary results?: No
  If yes - please enter the URL to summary results:
  If no – why not?: The acoustic data is difficult to publish.
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials:
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F38740729%252F%2FNBTI%2F0AHDAQ%2FAQ%2F11b7fe84-1637-47c2-98ea-5708a313857e%2F2%2FyERcRyx97L&data=05%7C02%7Ccambridgecentral.rec%40hra.nhs.uk%7Cbc72311a9531492cd13108de5dde99ee%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639051407808350857%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=sWHHjAUC5LzVMP6n99wvNGPdoSPaqjISxdN9GHF6urQ%3D&reserved=0
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
  If yes, describe and/or provide URLs to materials shared and how they were shared: They were informed verbally
  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared:
  If no, explain why sharing hasn't been enabled: Difficult to share acoustic data.
  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: No tissue samples taken in this study.
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• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  23/YH/0044

• Date of REC Opinion

  12 Apr 2023

• REC opinion

  Further Information Favourable Opinion