The Accuracy of Sonotubometry to Assess the Eustachian Tube

NCT ID: NCT05740384

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2023-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Sonotubometry Assessment

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

James Tysome

OTHER

Sponsor Role: lead

Responsible Party

James Tysome

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

James Tysome, Dr

Role: PRINCIPAL_INVESTIGATOR

Cambridge University Hospitals NHS Foundation Trust

Locations

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Tobia Nava, MSc

Role: CONTACT

tsn23@cam.ac.uk

0044 7311213580

James Tysome, Dr

Role: CONTACT

jrt20@cam.ac.uk

Facility Contacts

James Tysome, Dr

Role: primary

Other Identifiers

A096497

Identifier Type: -

Identifier Source: org_study_id