CoughNCT06579989
Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures
A study testing Ultrasound for cough, Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis and Ultrasound for dysphagia in people with Cough and Vocal Cord Atrophy, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Investigators will assess the usefulness of using ultrasound in office procedures for laryngology interventions. Participants who qualify will be adults who are undergoing superior laryngeal nerve block, injection laryngoplasty, swallowing evaluation, voice evaluation and voice therapy. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough, Vocal Cord Atrophy, Vocal Cord Paresis
- What is being tested?
- Ultrasound for cough, Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis and Ultrasound for dysphagia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- US-Guided Injection for Neurogenic Cough:
- Age over 18 years
- Recommended to undergo superior laryngeal nerve block
- US-Assessment of Superior Laryngeal Nerve Anatomy
- Age over 18 years
- No cough complaints
Show all 19Show fewer
- US-Assessment of Injectate Volume:
- Documentation of unilateral vocal fold paresis/paralysis or atrophy
- Age over 18 years
- Recommended to undergo injection laryngoplasty
- US-Assessment of Swallow:
- Age over 18 years
- Presents with swallowing complaints
- US-Assessment of Normal Swallow:
- Age over 18 years
- Presents without swallowing complaints
- US-Assessment of Voice:
- Age over 18 years
- Undergoing evaluation of voice problems
Who cannot join
- Age under 18 years and over 99 years
- Open neck wound including tracheostomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Weill Cornell Medicine
New York, New York, 10021
John Ramos, BA, (646) 962-7464 ext. 19882, jmr4003@med.cornell.edu
Anaïs Rameau, MD, 646-962-7464, anr2783@med.cornell.edu
About this study
Official title: Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures: A Pilot Study
Investigators will assess the usefulness of using ultrasound in office procedures for laryngology interventions. Participants who qualify will be adults who are undergoing superior laryngeal nerve block, injection laryngoplasty, swallowing evaluation, voice evaluation and voice therapy.
- Conditions
- Cough, Vocal Cord Atrophy, Vocal Cord Paresis, Vocal Cord Paralysis, Dysphagia, Dysphonia
- Being tested
- Ultrasound for cough, Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis, Ultrasound for dysphagia, Ultrasound for dysphonia
- Medical subject headings
- Cough, Vocal Cord Paralysis, Deglutition Disorders, Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound for coughDiagnostic test
Adult patients who are seen at the Sean Parker Institute for the Voice and are determined to have neurogenic cough for which superior laryngeal nerve block is recommended will undergo this procedure under ultrasound guidance. Patients without neurogenic cough will also be recruited for ultrasound assessment to establish landmarks and normal variation. Patients will be assessed for their comfort with undergoing the procedure and clinicians will be surveyed on the ease and benefit of performing the procedure under ultrasound guidance.
Ultrasound for vocal fold atrophy or vocal fold paresis/paralysisDiagnostic test
Adult patients who are seen at the Sean Parker Institute for the Voice and are determined to have vocal fold atrophy or vocal fold paresis/paralysis for whom injection laryngoplasty is recommended will undergo laryngeal ultrasound prior to the procedure to assess baseline anatomy as well as following the procedure (both immediately following the procedure as well as at follow-up visits) in order to assess the amount of injectate.
Ultrasound for dysphagiaDiagnostic test
Patients with and without swallowing complaints will be enrolled to assess their tongue, suprahyoid and infrahyoid musculature, including muscle identification, bulk and function.
Ultrasound for dysphoniaDiagnostic test
Adult patients who are seen at the Sean Parker Institute for the Voice and are determined to have muscle tension dysphonia will undergo ultrasonography during their visit with laryngology or speech language pathology.
| Study group | Role | What they receive |
|---|---|---|
| Cough | Experimental | Adult patients who are seen at the Sean Parker Institute for the Voice and are determined to have neurogenic cough for which superior laryngeal nerve block is recommended will undergo this procedure under ultrasound guidance. Patients without neurogenic cough will also be recruited for ultrasound assessment to establish landmarks and normal variation. Receives: Diagnostic Test: Ultrasound for cough |
| Vocal Cord Atrophy | Experimental | Adult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study. Receives: Diagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis |
| Vocal Cord Paresis | Experimental | Adult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study. Receives: Diagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis |
| Vocal Cord Paralysis | Experimental | Adult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study. Receives: Diagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis |
| Dysphagia | Experimental | Adult patients referred to the Sean Parker Institute for the Voice for swallowing assessment will undergo standard medical history including collection of age, gender, occupation, characteristics of swallowing complaints, and prior evaluation and treatments. Adult patients without swallowing complaints will also be recruited to define normal anatomy and variation. Receives: Diagnostic Test: Ultrasound for dysphagia |
| Dysphonia | Experimental | Adult patients referred to the Sean Parker Institute for the Voice for voice assessment will undergo standard medical history including collection of age, gender, occupation, characteristics of voice complaints, and prior evaluation and treatments. Additionally, patients diagnosed with muscle tension dysphonia will be evaluated by ultrasound for the presence, size, and function of their suprahyoid musculature. Receives: Diagnostic Test: Ultrasound for dysphonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.
The clinician will use the Likert scale and rate a series of statements on a scale of 1 (strongly disagree) to 5 (strongly agree). The lowest possible total score is 12 (overall clinician disagreement), and the highest possible total score is 60 (overall clinician agreement).
Measured: Immediately post-intervention
Qualitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.
The clinician will respond to the following open-ended questions:
- What are the benefits with performing the procedure with ultrasound?
- What are the limitations with performing this procedure with ultrasound?
Measured: Immediately post-intervention
Patient comfort measures during ultrasound-guided injection of the internal branch of superior laryngeal nerve for neurogenic cough.
Number of patients that fall into the below categories as determined by the provider care team:
- No discomfort: talking/comfortable throughout
- Minimal discomfort: 1 or 2 episodes of mild discomfort with no distress
- Mild discomfort: More than 2 episodes of discomfort without distress
- Moderate discomfort: significant discomfort experienced several times with some distress
- Severe discomfort: frequent discomfort with significant distress
Measured: Day 1
Time to complete superior laryngeal nerve injection under ultrasound.
The amount of time will be recorded in minutes.
Measured: Day 1
Images and descriptors of internal branch of superior laryngeal nerve anatomy and normal variation.
This is a qualitative outcome measure. Providers will provide a description of the internal branch of superior laryngeal nerve anatomy with accompanying images from the strobe.
Measured: Day 1
Change in volume of injectate in injection laryngoplasty measured by ultrasound compared to amount injected after procedure and at follow-up.
The volume will be recorded in mL.
Measured: Immediately post-intervention and at 4 week follow-up visit
Presence, bulk, and function of tongue, suprahyoid, and infrahyoid musculature on ultrasound for patients with and without swallowing complaints.
This is a qualitative outcome measure. Providers will provide a description of the tongue, suprahyoid, and infrahyoid musculature on ultrasound for patients with and without swallowing complaints.
Measured: Day 1
Evaluation of suprahyoid musculature on ultrasound for patients with muscle tension dysphonia.
This is a qualitative outcome measure. Providers will provide a description of the suprahyoid musculature on ultrasound for patients with muscle tension dysphonia.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anaïs Rameau, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579989
- Sponsor's protocol ID
- 23-10026663
- Status last verified
- Jun 2026
- First submitted
- 19 Aug 2024
- Last updated
- 16 Jun 2026
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures: A Pilot Study
- ClinicalTrials.gov ID
- NCT06579989
- Acronym / sponsor ID
- 23-10026663
- Conditions
- Cough, Vocal Cord Atrophy, Vocal Cord Paresis, Vocal Cord Paralysis, Dysphagia, Dysphonia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 30 Aug 2024 (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.
Investigators will assess the usefulness of using ultrasound in office procedures for laryngology interventions. Participants who qualify will be adults who are undergoing superior laryngeal nerve block, injection laryngoplasty, swallowing evaluation, voice evaluation and voice therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cough | Experimental | Diagnostic Test: Ultrasound for coughAdult patients who are seen at the Sean Parker Institute for the Voice and are determined to have neurogenic cough for which superior laryngeal nerve block is recommended will undergo this procedure under ultrasound guidance. Patients without neurogenic cough will also be recruited for ultrasound assessment to establish landmarks and normal variation. |
| Vocal Cord Atrophy | Experimental | Diagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysisAdult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study. |
| Vocal Cord Paresis | Experimental | Diagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysisAdult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study. |
| Vocal Cord Paralysis | Experimental | Diagnostic Test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysisAdult patients with vocal fold atrophy, paresis, or paralysis diagnosed at the Sean Parker Institute for the Voice who are planned to undergo injection laryngoplasty will be invited to take part in the study. |
| Dysphagia | Experimental | Diagnostic Test: Ultrasound for dysphagiaAdult patients referred to the Sean Parker Institute for the Voice for swallowing assessment will undergo standard medical history including collection of age, gender, occupation, characteristics of swallowing complaints, and prior evaluation and treatments. Adult patients without swallowing complaints will also be recruited to define normal anatomy and variation. |
| Dysphonia | Experimental | Diagnostic Test: Ultrasound for dysphoniaAdult patients referred to the Sean Parker Institute for the Voice for voice assessment will undergo standard medical history including collection of age, gender, occupation, characteristics of voice complaints, and prior evaluation and treatments. Additionally, patients diagnosed with muscle tension dysphonia will be evaluated by ultrasound for the presence, size, and function of their suprahyoid musculature. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- US-Guided Injection for Neurogenic Cough:
- US-Assessment of Superior Laryngeal Nerve Anatomy
- US-Assessment of Injectate Volume:
- US-Assessment of Swallow:
- US-Assessment of Normal Swallow:
Key exclusion criteria (2 listed)
- Age under 18 years and over 99 years
- Open neck wound including tracheostomy
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 |
|---|---|---|
| Ultrasound for coughAdult patients who are seen at the Sean Parker Institute for the Voice and are determined to have neurogenic cough for which superior laryngeal nerve block is recommended will undergo this procedure under ultrasound guidance. Patients without neurogenic cough will also be recruited for ultrasound assessment to establish landmarks and normal variation. Patients will be assessed for their comfort with undergoing the procedure and clinicians will be surveyed on the ease and benefit of performing the procedure under ultrasound guidance. | Diagnostic test | Cough |
| Ultrasound for vocal fold atrophy or vocal fold paresis/paralysisAdult patients who are seen at the Sean Parker Institute for the Voice and are determined to have vocal fold atrophy or vocal fold paresis/paralysis for whom injection laryngoplasty is recommended will undergo laryngeal ultrasound prior to the procedure to assess baseline anatomy as well as following the procedure (both immediately following the procedure as well as at follow-up visits) in order to assess the amount of injectate. | Diagnostic test | Vocal Cord Atrophy, Vocal Cord Paralysis, Vocal Cord Paresis |
| Ultrasound for dysphagiaPatients with and without swallowing complaints will be enrolled to assess their tongue, suprahyoid and infrahyoid musculature, including muscle identification, bulk and function. | Diagnostic test | Dysphagia |
| Ultrasound for dysphoniaAdult patients who are seen at the Sean Parker Institute for the Voice and are determined to have muscle tension dysphonia will undergo ultrasonography during their visit with laryngology or speech language pathology. | Diagnostic test | Dysphonia |
Primary outcome
Quantitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.
Time frame: Immediately post-intervention
The clinician will use the Likert scale and rate a series of statements on a scale of 1 (strongly disagree) to 5 (strongly agree). The lowest possible total score is 12 (overall clinician disagreement), and the highest possible total score is 60 (overall clinician agreement).
Qualitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough.
Time frame: Immediately post-intervention
The clinician will respond to the following open-ended questions: * What are the benefits with performing the procedure with ultrasound? * What are the limitations with performing this procedure with ultrasound?
Patient comfort measures during ultrasound-guided injection of the internal branch of superior laryngeal nerve for neurogenic cough.
Time frame: Day 1
Number of patients that fall into the below categories as determined by the provider care team: * No discomfort: talking/comfortable throughout * Minimal discomfort: 1 or 2 episodes of mild discomfort with no distress * Mild discomfort: More than 2 episodes of discomfort without distress * Moderate discomfort: significant discomfort experienced several times with some distress * Severe discomfort: frequent discomfort with significant distress
Time to complete superior laryngeal nerve injection under ultrasound.
Time frame: Day 1
The amount of time will be recorded in minutes.
Images and descriptors of internal branch of superior laryngeal nerve anatomy and normal variation.
Time frame: Day 1
This is a qualitative outcome measure. Providers will provide a description of the internal branch of superior laryngeal nerve anatomy with accompanying images from the strobe.
Change in volume of injectate in injection laryngoplasty measured by ultrasound compared to amount injected after procedure and at follow-up.
Time frame: Immediately post-intervention and at 4 week follow-up visit
The volume will be recorded in mL.
Presence, bulk, and function of tongue, suprahyoid, and infrahyoid musculature on ultrasound for patients with and without swallowing complaints.
Time frame: Day 1
This is a qualitative outcome measure. Providers will provide a description of the tongue, suprahyoid, and infrahyoid musculature on ultrasound for patients with and without swallowing complaints.
Evaluation of suprahyoid musculature on ultrasound for patients with muscle tension dysphonia.
Time frame: Day 1
This is a qualitative outcome measure. Providers will provide a description of the suprahyoid musculature on ultrasound for patients with muscle tension dysphonia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- 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.
Anaïs Rameau, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound for cough, Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis and Ultrasound for dysphagia in people with Cough and Vocal Cord Atrophy, run by Weill Medical College of Cornell University at 1 site in United States.
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 19 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: opening soon, as of the sponsor's last update on 16 Jun 2026. 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 States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Ramos, BA ((646) 962-7464 ext. 19882, jmr4003@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative clinician-reported usability measure of ultrasound during injection of the internal branch of superior laryngeal nerve for neurogenic cough. (time frame: Immediately post-intervention). The study lists 8 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 16 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.