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Neurological DisorderNCT05493397

Ultrasound to Detect Vocal Fold Movement in Neurological Disease

An observational study of Neurological Disorder and Ultrasound, run by University College, London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to investigate the accuracy and viability of transcutaneous laryngeal ultrasound (US) in detecting impairments of vocal fold movement in people with neurological disorders. Read more about this study

Who is it for?
Ages 18 years and older
How many people
20 participants
Where
1 siteUnited Kingdom
Study dates
1 Aug 2022to 30 Sep 2024
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive patients with neurological impairment due to be referred to Ear, Nose and Throat (ENT)services with suspected impairment of vocal fold function.

Who may be able to join

  • Patients under in-patient our out-patient Speech and Language Therapy care at primary study site.
  • Patients with a neurological condition who have a suspected impairment of vocal fold movement due to diagnosis of dysphonia, breathing difficulties and/or impaired cough as determined by their lead Speech and Language Therapist.
  • Over 18 years old
  • Has undergone/will undergo nasendoscopy as part of their standard clinical care.

Who cannot join

  • Patients who cannot be supported to demonstrate capacity to consent.
  • Any patient that automatically meets the clinical exclusion criteria for FNE; e.g. epistaxis risk, facial fracture, patient distress.
  • Patients who do not have sufficient command of English to consent in this study will also be excluded from the study due to limited resources for advocacy services. Participants will require sufficient English language skills to participate in the patient questionnaire.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University College London Hospitals

    London, WC1N 3BG

Other trials in United Kingdom

About this study

Official title: A Feasibility Study to Investigate the Accuracy and Viability of Ultrasound in Detecting Impairments of Vocal Fold Mobility in People With Neurological Disease

This study aims to investigate the accuracy and viability of transcutaneous laryngeal ultrasound (US) in detecting impairments of vocal fold movement in people with neurological disorders.

The accuracy and viability of laryngeal US compared with reference standard fibreoptic nasendoscopic examination (FNE) will be evaluated. The study also includes measurements of clinician reliability in US image acquisition and interpretation, and assess the acceptability of US assessment to people with neurological disorders. Data will be used to assess the ability of US to detect other laryngeal pathology, and to calculate the sample size required for a validation study.

Read the detailed description

The availability of cheaper and more portable ultrasound (US) machines has resulted in the extension of the use of US beyond the radiology department into diverse clinical areas. In particular, the Covid-19 pandemic has intensified interest in US as an alternative tool to use within the Speech and Language Therapy (SLT) profession to assess swallowing and airway disorders as access to routine assessment tools such as fibreoptic endoscopic examination (FNE) was restricted to its due aerosol-generating properties (Bolton et al., 2020).

The use of US by allied health professionals, such as Speech and Language Therapists (SLTs), is driven by National Institute for Health and Care Excellence (NICE) guidance and government policy (The Royal College of Radiologists, 2017) whereby the range of applications and locations where US can be used makes it impractical to deliver this imaging using radiologists or sonographers alone.

The application of laryngeal US is not new within the medical profession and there is considerable mounting evidence to support both the diagnostic ability and feasibility of laryngeal US for diagnosing impairments of vocal fold movement. Laryngeal US has been found to have both high sensitivity and specificity in diagnosing disorders of vocal fold movement in the post-surgical (specifically thyroid) population. Findings of a recent rapid review exploring the utility of laryngeal US for the assessment of vocal fold function revealed a sensitivity and specificity of 100% to detect normal versus disordered vocal fold function with a linear probe with range frequencies (e.g.6-13Hz) (Allen et al., 2020). To date, there are no studies exploring use of laryngeal US in assessing vocal fold movement in neurological conditions, despite the prominence of vocal fold impairments in this patient group.

In addition to increased accuracy, laryngeal US has many other advantages as an assessment and monitoring tool. Arguably, the greatest advantage of laryngeal US over FNE is its bedside accessibility and potential avoidance of intrusive procedures. This is particularly paramount in patients that require multiple invasive procedures, for example, combined FNE and non-invasive ventilation, cough augmentation, suction, nasogastric tube feeding and high flow oxygen therapy. Furthermore, if evaluation by laryngeal US was led by SLT, it would not require patient transport to Ear, Nose \& Throat (ENT) clinics or presence of an ENT consultant at bedside; potentially expediting access to diagnosis of vocal fold function impairments and reducing cost.

A trained SLT could utilise US to identify presence or absence of vocal fold function impairment in patients with neurological disease. Primary examples are cases where vocal fold impairment is a known or anticipated symptom of the underlying neurological condition (such as brainstem stroke, multiple system atrophy and/or neuromuscular conditions such as Charot Marie Tooth disease). In these cases, the SLT could assess using laryngeal US to ascertain a vocal fold diagnosis to inform timely management or treatment plan. In cases where intrusive respiratory interventions may provoke issues with vocal fold movement (such as cough augmentation) the SLT can provide non-invasive 'real-time' monitored laryngeal US assessment which will directly influence combined SLT and physiotherapy management in patients with combined bulbar and respiratory disease. They could also use US to inform the relative urgency of subsequent ENT opinion. This is particularly pertinent at NHNN where there is no on-site access to ENT.

This research project is designed to improve the care pathway for patients with suspected vocal fold mobility impairment secondary to neurological disease. The current standard of practice for patients with suspected impairment of vocal fold mobility at our tertiary neurological centre is referral for routine assessment by an ENT doctor. The timescale from referral to assessment can be up to 12 weeks. FNE is an intrusive procedure requiring placement of a flexible scope into the throat via the nose. This can be uncomfortable for patients and, in some cases, contraindicated (Langmore, 2001). The clinical cost of an ENT-led nasendoscopy is £645. The procedure also requires pre- and post- assessment time and expertise for decontamination of the nasendoscope. Whereas, the cost of the US, led by and SLT is £62. The decontamination process is quick (using a simple wipe) and therefore more cost effective. Laryngeal US examination can be performed by an SLT within 48 hours of referral, leading to more timely assessment and intervention. Furthermore, preliminary findings from our patient advisory group indicate that US is a more comfortable and tolerable assessment. The outcomes of this study has the potential to influence clinical pathways at our tertiary centre to provide a service that is rapid, non-intrusive and cost-effective in the assessment for early diagnosis and management of vocal fold impairment.

This is a prospective cross-sectional mixed-methods study of consecutive patients referred from our tertiary neurological centre to ENT services for an assessment of their vocal fold mobility.

The study is to be conducted at a single-site, specialist tertiary centre, specialising in the diagnosis, assessment, and management of neurological disorders. It will adopt a cross-sectional design and aim to capture consecutive in- and out-patients with suspected vocal fold movement impairment referred to ENT for vocal fold assessment over the course of 12 months.

The anticipated sample size is n=50 patients.

Each research participant will be assessed once. The assessment will include the following (in order):

  1. Invitation to participate which will include a patient information leaflet.
  2. Signed consent.
  3. TWO assessments, one of which is part of routine clinical care. These assessments are FNE and ii) Laryngeal US. FNE will be performed either by an ENT consultant or experienced SLT. A small, flexible camera is passed into the nose to view the throat. This assessment is part of routine clinical care (and is the current gold-standard for assessment for vocal fold movement. Laryngeal US uses a hand-held probe on the skin of the neck to assess the throat from the outside. Lubricating gel is used to improve contact between the skin and the probe. Each assessment will take less then 10 minutes to perform.
  4. Participant survey. Each participant will be asked to complete a short (5-item) questionnaire to capture their experiences of undergoing each assessment.

As per usual clinical care - participants will receive a diagnosis from the ENT consultant based on the images from the FNE. They will be offered the opportunity to be contacted about the findings of the research study once data analysis is complete.

Medical subject headings
Nervous System Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of transcutaneous laryngeal US in the diagnosis of vocal fold movement impairment in patients with neurological disease.

    Each participant with be assessed using i) laryngeal ultrasound (US) and ii) fibreoptic nasendoscopic examination (FNE). One ENT or SLT will pass an FNE to assess vocal fold function. Images will be interpreted by an ENT consultant blinded to the outcomes of the laryngeal US. Two blinded SLTs will capture and interpret laryngeal US images. Each SLT will be blinded to the outcomes of i) the FNE assessment and ii) their SLT peer US assessment. Vocal fold movement will be assessed using a three-point scale (0 - normal movement, 1- impaired movement, 2- no movement).

    Descriptive and inferential statistics will be used to establish the sensitivity and specificity of laryngeal US in detecting an impairment of vocal fold movement impairment. A consensus agreement between the two blinded SLTs will be used to calculate the sensitivity and specificity.

    Measured: 12 months

  2. Technical and environmental viability of laryngeal US in patients with neurological disease.

    Image acquisition scored on a binary scale (possible/not possible). Any technical or environmental factors preventing US image acquisition will be captured on a pre-determined spread sheet.

    Measured: 12 months

Secondary outcomes (4)
  1. Reliability of assessors in capturing and interpreting laryngeal US images for the purpose of vocal fold movement assessment in patients with neurological disease.

    Inter-rater reliability of the SLT US assessors will be calculated using kappa statistic.

    Measured: 15 months

  2. Acceptability of transcutaneous laryngeal US to patients with neurological disease.

    Each patient will be asked to complete a short survey about their experience of laryngeal US assessment. Quantitative data will be analysed descriptively. Qualitative data will be analysed using thematic analysis.

    Measured: 15 months

  3. Diagnostic accuracy and feasibility of laryngeal US between patients of different neurological disease groups

    Sub-group analysis will be used to explore the accuracy and feasibility of laryngeal US according to neurological diagnosis.

    Measured: 15 months

  4. Ability of US to detect other laryngeal pathology in patients with neurological disease.

    Where additional laryngeal pathology was diagnosed on FNE, retrospective analysis of these images will be conducted alongside US images to generate hypothesis relating to the ability of US to detect other laryngeal pathology in this patient group. Findings will be descriptive.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2022
  2. Study start1 Aug 2022
  3. Primary completion30 Sep 2024
  4. Study completion30 Sep 2024

Resources

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05493397
Sponsor's protocol ID
146531
Status last verified
Aug 2025
First submitted
5 Aug 2022
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bolton L, Mills C, Wallace S, Brady MC; Royal College of Speech and Language Therapists (RCSLT) COVID-19 Advisory Group. Aerosol generating procedures, dysphagia assessment and COVID-19: A rapid review. Int J Lang Commun Disord. 2020 Jul;55(4):629-636. doi: 10.1111/1460-6984.12544. Epub 2020 Jun 1. No abstract available.

    PubMed 32478950
  • Allen J, Clunie G, Slinger C et al. Utility of ultrasound in the assessment of swallowing and laryngeal function: A rapid review and critical appraisal of the literature. International Journal of Language and Communication Disorders 2021 56 (1): 174-204.

  • Langmore SE. Endoscopic Evaluation and Treatment of Swallowing Disorders. 2001. New York: Thieme Publishers

Questions about this trial

What is this clinical trial studying?

An observational study of Neurological Disorder and Ultrasound, run by University College, London 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 19 Aug 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of transcutaneous laryngeal US in the diagnosis of vocal fold movement impairment in patients with neurological disease. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05493397, which also lists 3 linked publications.

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 19 Aug 2025.

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