Clinical trial NCT05740384: The Accuracy of Sonotubometry to Assess the Eustachian Tube
Official title: Assessing the Sensitivity and Specificity of Sonotubometry to Measure the Eustachian Tube Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eustachian Tube Dysfunction
Keywords: obstructive Eustachian tube dysfunction
Eustachian tube dysfunction
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2023-02-23
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a validation study in 28 ears with Eustachian tube dysfunction.
Primary purpose: DIAGNOSTIC

Brief 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 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)

Primary outcomes:
measure: Assess Specificity and Sensitivity of Sonotubometry using a Custom-Built Sonotubometer
timeFrame: 40-50 minutes
Secondary outcomes:
measure: Ability of Sonotubometry Measurements to detect Eustachian tube opening by using an Increased Sound Amplitude
timeFrame: 40-50 minutes
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: James Tysome, Dr
role: PRINCIPAL_INVESTIGATOR
References: