The Accuracy of Sonotubometry to Assess the Eustachian Tube

Assessing the Sensitivity and Specificity of Sonotubometry to Measure the Eustachian Tube Function

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.

Study Overview

• Status: Recruiting
• Conditions: Eustachian Tube Dysfunction
• Intervention / Treatment: Device: Sonotubometry Assessment

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobia Nava, MSc; Phone Number: 0044 7311213580; Email: tsn23@cam.ac.uk
• Study Contact Backup: Name: James Tysome, Dr; Email: jrt20@cam.ac.uk

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Recruiting
      • Cambridge University Hospitals NHS Foundation Trust
      • Contact: James Tysome, Dr
      • Sub-Investigator: Tobia Nava, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sonotubometry Assessment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of Sonotubometry Measurements to detect Eustachian tube opening by using an Increased Sound Amplitude	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)	40-50 minutes

Collaborators and Investigators

• Sponsor: James Tysome
• Collaborators: University of Cambridge
• Investigators: Principal Investigator: James Tysome, Dr, Cambridge University Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Eustachian tube dysfunction; obstructive Eustachian tube dysfunction
• Other Study ID Numbers: A096497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No