Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures

June 12, 2026 updated by: Weill Medical College of Cornell University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medicine
        • Contact:
        • Principal Investigator:
          • Anaïs Rameau, MD
        • Sub-Investigator:
          • Christine Clark, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • US-Guided Injection for Neurogenic Cough:

    1. Age over 18 years
    2. Recommended to undergo superior laryngeal nerve block

  • US-Assessment of Superior Laryngeal Nerve Anatomy

    1. Age over 18 years
    2. No cough complaints

  • US-Assessment of Injectate Volume:

    1. Documentation of unilateral vocal fold paresis/paralysis or atrophy
    2. Age over 18 years
    3. Recommended to undergo injection laryngoplasty

  • US-Assessment of Swallow:

    1. Age over 18 years
    2. Presents with swallowing complaints

  • US-Assessment of Normal Swallow:

    1. Age over 18 years
    2. Presents without swallowing complaints

  • US-Assessment of Voice:

    1. Age over 18 years
    2. Undergoing evaluation of voice problems

Exclusion Criteria:

  1. Age under 18 years and over 99 years
  2. Open neck wound including tracheostomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cough
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.
Diagnostic test: Ultrasound for cough
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.
Experimental: Vocal Cord Atrophy
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.
Diagnostic test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis
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.
Experimental: Vocal Cord Paresis
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.
Diagnostic test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis
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.
Experimental: Vocal Cord Paralysis
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.
Diagnostic test: Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis
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.
Experimental: Dysphagia
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.
Diagnostic test: Ultrasound for dysphagia
Patients with and without swallowing complaints will be enrolled to assess their tongue, suprahyoid and infrahyoid musculature, including muscle identification, bulk and function.
Experimental: Dysphonia
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.
Diagnostic test: Ultrasound for dysphonia
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Immediately post-intervention
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?
Immediately post-intervention
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
Day 1
Time to complete superior laryngeal nerve injection under ultrasound.
Time Frame: Day 1
The amount of time will be recorded in minutes.
Day 1
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.
Day 1
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.
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.
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.
Day 1
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Weill Medical College of Cornell University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anaïs Rameau, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-10026663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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