The Accuracy of Sonotubometry to Assess the Eustachian Tube

Not Applicable

Recruiting

• Conditions: Eustachian Tube Dysfunction

• Registration Number: NCT05740384
• Lead Sponsor: James Tysome

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-23
• Study Start: 2023-04-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-06
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assess Specificity and Sensitivity of Sonotubometry using a Custom-Built Sonotubometer	40-50 minutes	The main objective of the trial is to measure the specificity and sensitivity of an assessment method of the Eustachian tube called sonotubometry. To do this, eight sonotubometry measurements will be performed on each patient using the custom built Sonotubometry device. In total a maximum of 28 patients will be measured. This data will be compared to measurements from volunteers (data collected through a different study) to measure the sensitivity and specificity in percentage.

Secondary Outcome Measures

Name	Time	Method
Ability of Sonotubometry Measurements to detect Eustachian tube opening by using an Increased Sound Amplitude	40-50 minutes	The secondary objective is to assess if sonotubometry with an sound amplitude of 120dB is able to detect Eustachian tube opening. In the past a lower sound level was used (below 110dB) and thus the goal here is to measure the suitability of a higher sound pressure for sonotubometry. This will be measured by the ability of the new method to reliably detect the Eustachian tube function in patients and healthy volunteers (healthy volunteers data was gathered in a separate study)

Trial Locations

Locations (1)

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom