The Accuracy of Sonotubometry to Assess the Eustachian Tube

NCT05740384 | Unknown

• 1 other identifier: A096497
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Eustachian Tube Dysfunction

Keywords

obstructive Eustachian tube dysfunction; Eustachian tube dysfunction

Outcome Measures

Primary Outcomes (1)

• Assess Specificity and Sensitivity of Sonotubometry using a Custom-Built Sonotubometer

  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.

  40-50 minutes

Secondary Outcomes (1)

• Ability of Sonotubometry Measurements to detect Eustachian tube opening by using an Increased Sound Amplitude

  40-50 minutes

Study Arms (1)

Sonotubometry Assessment

EXPERIMENTAL

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.

Device: Sonotubometry Assessment

Interventions

Sonotubometry Assessment DEVICE

The exact order of the measurements will be randomised: * Recording type 1: No sound applied, 10 seconds recording of baseline noise, followed by recording when the participant is asked to swallow 3 times. * Recording type 2: White noise applied, 10 seconds recording of baseline noise, followed by recording when the participant is asked to swallow 3 times. * Ask for subjective feedback (did you hear a change in the sound in your ear on swallowing?) after each recording * This is repeated using the contralateral ear and nostril. After successful recording, the microphone will be removed. For comparison, tubomanometry measurements will be performed on each ear. Tubomanometry is an alternative method to assess the middle ear and Eustachian tube. Afterwards, the participant's involvement in the study will be complete. The entire involvement will take about 50 minutes.

Sonotubometry Assessment

Eligibility Criteria

• Age: 16 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• James Tysome: lead
• University of Cambridge: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Study Officials

• James Tysome, Dr

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobia Nava, MSc

CONTACT

0044 7311213580; tsn23@cam.ac.uk

James Tysome, Dr

CONTACT

jrt20@cam.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The order of the assessment measurements is batch-wise randomised but there is no masking. Both the participant and investigator know what sort of measurements is being performed.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a validation study in 28 ears with Eustachian tube dysfunction.

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 23, 2023
• Study Start: April 21, 2023
• Primary Completion: September 30, 2023
• Study Completion: December 30, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

GB (1)