Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures

NCT ID: NCT06579989

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cough Vocal Cord Atrophy Vocal Cord Paresis Vocal Cord Paralysis Dysphagia Dysphonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ultrasound for cough

Intervention Type DIAGNOSTIC_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.

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.

Group Type EXPERIMENTAL

Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis

Intervention Type DIAGNOSTIC_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.

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.

Group Type EXPERIMENTAL

Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis

Intervention Type DIAGNOSTIC_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.

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.

Group Type EXPERIMENTAL

Ultrasound for vocal fold atrophy or vocal fold paresis/paralysis

Intervention Type DIAGNOSTIC_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.

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.

Group Type EXPERIMENTAL

Ultrasound for dysphagia

Intervention Type DIAGNOSTIC_TEST

Patients with and without swallowing complaints will be enrolled to assess their tongue, suprahyoid and infrahyoid musculature, including muscle identification, bulk and function.

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.

Group Type EXPERIMENTAL

Ultrasound for dysphonia

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anaïs Rameau, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alexandra Li, BS

Role: CONTACT

(646) 962-7464 ext. 19882

Sara Albert, BA

Role: CONTACT

(646) 962-9883

Facility Contacts

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Alexandra Li, BS

Role: primary

646-962-7464 ext. 19882

Anaïs Rameau, MD

Role: backup

646-962-7464

Other Identifiers

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23-10026663

Identifier Type: -

Identifier Source: org_study_id

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