Vocal Cord DysfunctionNCT05686941
Is Laryngeal Ultrasound Useful in the Assessment for ILO? A Protocol for a Two-stage Exploratory Pilot Study
An observational study of Vocal Cord Dysfunction and Asthma Brittle, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study is a feasibility study to see if an ultrasound scan of the vocal cords can detect narrowing of the vocal cords as seen in a condition called inducible laryngeal Obstruction (the vocal cords narrow or close on breathing in, which makes it very difficult to breathe). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vocal Cord Dysfunction, Asthma Brittle, Inducible Laryngeal Obstruction
- What is being tested?
- Trans-cutaneous Laryngeal ultrasound (TLUS) and TLUS and simultaneous laryngoscopy
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Aug 2022to 27 Jun 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * No definite signs or symptoms of vocal fold paralysis * No of history laryngeal surgeries * No history of pathology pathology * Too anxious to undergo procedure
Who may be able to join
- Healthy volunteers:
- No definite signs or symptoms of vocal fold paralysis
- No voice change
- No history laryngeal surgeries
- No History of pathology
- No uncontrolled Respiratory disease
Who cannot join
- Participants with a known vocal fold pathology
- Participants with a history of head and neck surgery.
Trial locations and contacts
1 site in 1 country.
Kina Bennett contact
United Kingdom1 site, 1 recruiting
- Recruiting
Lancashire Teaching Hospitals NHS Trust
Preston, Lancashire, PR2 9HT
Kina Bennett, kina.bennett@lthtr.nhs.uk
Claire Slinger
About this study
Official title: Is Laryngeal Ultrasound a Useful Tool in the Assessment of Inducible Laryngeal Obstruction? A Protocol for a Two-stage Exploratory Pilot Study
This study is a feasibility study to see if an ultrasound scan of the vocal cords can detect narrowing of the vocal cords as seen in a condition called inducible laryngeal Obstruction (the vocal cords narrow or close on breathing in, which makes it very difficult to breathe).
Read the detailed description
This study aims to help understand whether viewing the vocal cords with an ultrasound device is useful to detect the movement of the vocal cords during breathing. This study is useful, as some people who have abnormal movements of the vocal cords on breathing in find it more difficult to breathe in, and often this leads to a big impact on their quality of life. It may also mean they are on medications that they may not need not be on, as abnormal movements of the vocal cords can often be mistaken for asthma, so they may have been placed on asthma medication when they may not need to be.
Usually, the way the abnormal movements of the vocal cords are seen now is via a small camera is placed via the nose into the throat to directly look at the vocal cords. Some people find this uncomfortable and may have to wait for a long time for it to happen. Also, this procedure is expensive, and is done in an endoscopy theatre, which may make it more daunting for some people, and make the wait longer. There are only a few centres that do these assessments with the camera, so people may have to travel some distance to have an assessment.
It is hoped, by doing this study, the investigators can see whether ultrasound can help assess if people have abnormal vocal cord movements when they breathe in. This will be done in 2 stages, one with healthy volunteers, and the second stage in patients who have been referred for assessment of their vocal cords to see if they have abnormal movements when breathing in. The investigators will also ask the volunteers and patients what their experience of having the ultrasound was like, and will ask the patients in the study how the ultrasound scan felt, when compared to the camera test
- Conditions
- Vocal Cord Dysfunction, Asthma Brittle, Inducible Laryngeal Obstruction, Paradoxical Vocal Fold Motion
- Being tested
- Trans-cutaneous Laryngeal ultrasound (TLUS), TLUS and simultaneous laryngoscopy
- Keywords
- Inducible laryngeal obstruction, Ultrasound
- Medical subject headings
- Vocal Cord Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-cutaneous Laryngeal ultrasound (TLUS)Other
Assessment of the larynx (specifically the vocal cords) with hand held portable ultrasound device to assess the movements of the vocal cords
TLUS and simultaneous laryngoscopyOther
Also called TLUS
Assessment of the larynx (specifically the vocal cords) with hand held portable ultrasound device to assess the movements of the vocal cords with simultaneous video laryngoscopy (usual care)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Employees of the Host organisation in the Respiratory Team who meet the inclusion criteria Receives: Other: Trans-cutaneous Laryngeal ultrasound (TLUS) | |
| Patients with suspected Inducible laryngeal Obstruction (ILO) | Patients referred to a Tertiary referral centre who are suspected of having ILO Receives: Other: Trans-cutaneous Laryngeal ultrasound (TLUS); Other: TLUS and simultaneous laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of vocal cords that are seen with the ultrasound
Can the vocal cord be seen under TLUS for Healthy Volunteers? Numeric data.
Measured: 1 day
Number of particpants where visualisation of mimicked inspiratory adduction is visible on ultrasound
Can the vocal cords be seen to adduct under TLUS when healthy volunteers mimic ILO? Binary outcome: yes or no.
Measured: 1 day
To assess the sensitivity, specificity and positive predictive value of the use of ultrasound
To assess the sensitivity, specificity and positive predictive value of the use of ultrasound in the assessment of ILO, using Laryngoscopy as reference standard in the patient population (n=30)
Measured: 1 day
Questionnaire Investigating user perspectives on the acceptability of TLUS
A qualitative questionnaire investigating the patient and healthy volunteer perspectives on their experiences of undergoing TLUS assessment of the vocal cords. The questionnaire will look at the acceptability of the assessment in terms of comfort, repeatability, and comparison with laryngoscopy (for patients only).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start24 Aug 2022
- Primary completion27 Jun 2025 (estimated)
- Study completion27 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Edge Hill University, University College, London, Lancaster University, University of Central Lancashire
- Responsible party
- Principal investigator, Claire Slinger, Lancashire Teaching Hospitals NHS Foundation Trust
- Investigators
- Kina Bennett, Study chair, Lancashire Teaching Hospitals NHS TrustClaire Slinger, Principal investigator, Lancashire Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686941
- Sponsor's protocol ID
- 298631
- Status last verified
- Feb 2024
- First submitted
- 16 Dec 2022
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Laryngeal Ultrasound a Useful Tool in the Assessment of Inducible Laryngeal Obstruction? A Protocol for a Two-stage Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT05686941
- Acronym / sponsor ID
- 298631
- Conditions
- Vocal Cord Dysfunction, Asthma Brittle, Inducible Laryngeal Obstruction, Paradoxical Vocal Fold Motion
- Keywords
- Inducible laryngeal obstruction, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Edge Hill University, University College, London, Lancaster University, University of Central Lancashire
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 27 Jun 2025 (estimated)
- Study completion
- 27 Jun 2025 (estimated)
- First posted
- 17 Jan 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.
This study is a feasibility study to see if an ultrasound scan of the vocal cords can detect narrowing of the vocal cords as seen in a condition called inducible laryngeal Obstruction (the vocal cords narrow or close on breathing in, which makes it very difficult to breathe).
Detailed description
This study aims to help understand whether viewing the vocal cords with an ultrasound device is useful to detect the movement of the vocal cords during breathing. This study is useful, as some people who have abnormal movements of the vocal cords on breathing in find it more difficult to breathe in, and often this leads to a big impact on their quality of life. It may also mean they are on medications that they may not need not be on, as abnormal movements of the vocal cords can often be mistaken for asthma, so they may have been placed on asthma medication when they may not need to be.
Usually, the way the abnormal movements of the vocal cords are seen now is via a small camera is placed via the nose into the throat to directly look at the vocal cords. Some people find this uncomfortable and may have to wait for a long time for it to happen. Also, this procedure is expensive, and is done in an endoscopy theatre, which may make it more daunting for some people, and make the wait longer. There are only a few centres that do these assessments with the camera, so people may have to travel some distance to have an assessment.
It is hoped, by doing this study, the investigators can see whether ultrasound can help assess if people have abnormal vocal cord movements when they breathe in. This will be done in 2 stages, one with healthy volunteers, and the second stage in patients who have been referred for assessment of their vocal cords to see if they have abnormal movements when breathing in. The investigators will also ask the volunteers and patients what their experience of having the ultrasound was like, and will ask the patients in the study how the ultrasound scan felt, when compared to the camera test
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: Trans-cutaneous Laryngeal ultrasound (TLUS)Employees of the Host organisation in the Respiratory Team who meet the inclusion criteria |
| Patients with suspected Inducible laryngeal Obstruction (ILO) | – | Other: Trans-cutaneous Laryngeal ultrasound (TLUS), Other: TLUS and simultaneous laryngoscopyPatients referred to a Tertiary referral centre who are suspected of having ILO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * No definite signs or symptoms of vocal fold paralysis * No of history laryngeal surgeries * No history of pathology pathology * Too anxious to undergo procedure
Key inclusion criteria (6 listed)
- No definite signs or symptoms of vocal fold paralysis
- No voice change
- No history laryngeal surgeries
- No History of pathology
- No uncontrolled Respiratory disease
Key exclusion criteria (2 listed)
- Participants with a known vocal fold pathology
- Participants with a history of head and neck surgery.
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 |
|---|---|---|
| Trans-cutaneous Laryngeal ultrasound (TLUS)Assessment of the larynx (specifically the vocal cords) with hand held portable ultrasound device to assess the movements of the vocal cords | Other | Healthy Volunteers, Patients with suspected Inducible laryngeal Obstruction (ILO) |
| TLUS and simultaneous laryngoscopyAlso: TLUSAssessment of the larynx (specifically the vocal cords) with hand held portable ultrasound device to assess the movements of the vocal cords with simultaneous video laryngoscopy (usual care) | Other | Patients with suspected Inducible laryngeal Obstruction (ILO) |
Primary outcome
Number of vocal cords that are seen with the ultrasound
Time frame: 1 day
Can the vocal cord be seen under TLUS for Healthy Volunteers? Numeric data.
Number of particpants where visualisation of mimicked inspiratory adduction is visible on ultrasound
Time frame: 1 day
Can the vocal cords be seen to adduct under TLUS when healthy volunteers mimic ILO? Binary outcome: yes or no.
To assess the sensitivity, specificity and positive predictive value of the use of ultrasound
Time frame: 1 day
To assess the sensitivity, specificity and positive predictive value of the use of ultrasound in the assessment of ILO, using Laryngoscopy as reference standard in the patient population (n=30)
Questionnaire Investigating user perspectives on the acceptability of TLUS
Time frame: 1 day
A qualitative questionnaire investigating the patient and healthy volunteer perspectives on their experiences of undergoing TLUS assessment of the vocal cords. The questionnaire will look at the acceptability of the assessment in terms of comfort, repeatability, and comparison with laryngoscopy (for patients only).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Kina Bennett contact
Kina Bennett study chair
Lancashire Teaching Hospitals NHS Trust
Claire Slinger principal investigator
Lancashire Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vocal Cord Dysfunction and Asthma Brittle, run by Lancashire Teaching Hospitals NHS Foundation Trust 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 6 inclusion and 2 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 22 Feb 2024. 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 Claire Slinger (01171523237, claire.slinger@lthtr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of vocal cords that are seen with the ultrasound (time frame: 1 day). The study lists 4 primary outcomes in all. 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 22 Feb 2024.