The Accuracy of Sonotubometry to Assess the Eustachian Tube

Last updated: May 2, 2023
Sponsor: James Tysome
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ear Infections (Pediatric)

Ear Infections

Otitis Media

Treatment

Sonotubometry Assessment

Clinical Study ID

NCT05740384
A096497
  • Ages 16-64
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant is capable of giving informed consent (in the English language)
  • Participant has a current diagnosis of obstructive Eustachian tube dysfunction in theear clinic at Addenbrooke's Hospital
  • Age 16 and over

Exclusion

Exclusion Criteria:

  • Cardiac pacemaker (incompatible with the large sonotubometry speaker magnet)
  • Discharging or infected ear (for infection control reasons)
  • Otitis Media with effusion (complicates test interpretation)
  • Cleft palate or Craniofacial abnormalities (complicates test interpretation)
  • Cholesteatoma (complicates test interpretation)
  • Nasopharyngeal mass (complicates test interpretation)
  • History of radiotherapy to the head and neck (can affect surrounding tissue structure)

Study Design

Total Participants: 28
Treatment Group(s): 1
Primary Treatment: Sonotubometry Assessment
Phase:
Study Start date:
April 21, 2023
Estimated Completion Date:
December 30, 2023

Connect with a study center

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, Cambridgeshire CB2 0QQ
    United Kingdom

    Active - Recruiting

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