The Accuracy of Sonotubometry to Assess the Eustachian Tube

James Tysome

Status: Enrolling

Conditions: Eustachian Tube Dysfunction

Treatments: Device: Sonotubometry Assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT05740384

A096497

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 16 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Sonotubometry Assessment

Experimental group

Description:

All participants will be measured 8 times using sonotubometry. 2 times without applying any sound and 2 times while applying sound. This is done for both the left and right ear.

Treatment:

Device: Sonotubometry Assessment