Eustachian Tube DysfunctionNCT05740384
The Accuracy of Sonotubometry to Assess the Eustachian Tube
A study testing Sonotubometry Assessment in people with Eustachian Tube Dysfunction, run by James Tysome at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 64 years
- Conditions the study is for
- Eustachian Tube Dysfunction
- What is being tested?
- Sonotubometry Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
James Tysome, Dr contact
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
James Tysome, Dr
Tobia Nava, MSc
About this study
Official title: 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.
- Conditions
- Eustachian Tube Dysfunction
- Being tested
- Sonotubometry Assessment
- Keywords
- obstructive Eustachian tube dysfunction, Eustachian tube dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonotubometry AssessmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sonotubometry Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40-50 minutes
Secondary outcomes (1)
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)
Measured: 40-50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start21 Apr 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a validation study in 28 ears with Eustachian tube dysfunction.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James Tysome
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Sponsor-investigator, James Tysome, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- James Tysome, Dr, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740384
- Sponsor's protocol ID
- A096497
- Status last verified
- May 2023
- First submitted
- 31 Jan 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Sensitivity and Specificity of Sonotubometry to Measure the Eustachian Tube Function
- ClinicalTrials.gov ID
- NCT05740384
- Acronym / sponsor ID
- A096497
- Conditions
- Eustachian Tube Dysfunction
- Keywords
- obstructive Eustachian tube dysfunction, Eustachian tube dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- James TysomeUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a validation study in 28 ears with Eustachian tube dysfunction.
| Arm | Type | Receives |
|---|---|---|
| Sonotubometry Assessment | Experimental | Device: Sonotubometry AssessmentAll 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. |
Who may qualify
- Ages
- 16 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonotubometry AssessmentThe 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. | Device | Sonotubometry Assessment |
Primary outcome
Assess Specificity and Sensitivity of Sonotubometry using a Custom-Built Sonotubometer
Time frame: 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.
1 secondary outcome
Ability of Sonotubometry Measurements to detect Eustachian tube opening by using an Increased Sound Amplitude
Time frame: 40-50 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Tysome, Dr contact
James Tysome, Dr principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonotubometry Assessment in people with Eustachian Tube Dysfunction, run by James Tysome at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobia Nava, MSc (0044 7311213580, tsn23@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess Specificity and Sensitivity of Sonotubometry using a Custom-Built Sonotubometer (time frame: 40-50 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.