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Ultrasound for Throat Issues
N/A
Recruiting
Led By Anaïs Rameau, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
US-Assessment of Normal Swallow: Age over 18 years, Presents without swallowing complaints
US-Assessment of Superior Laryngeal Nerve Anatomy: Age over 18 years, No cough complaints
Must not have
Age under 18 years and over 99 years
Open neck wound including tracheostomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post-intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial will determine if ultrasound can be helpful during various office procedures for throat issues. Adults undergoing certain treatments and evaluations will be studied to see if ultrasound can improve the procedures. """
Who is the study for?
Adults with voice and swallowing issues like vocal cord paralysis, weakness, atrophy, hoarseness, coughing, or difficulty swallowing may join. Specific details on who can't participate are not provided.
What is being tested?
The trial is testing the use of ultrasound in routine office procedures for patients with laryngeal conditions. It will evaluate how helpful and practical ultrasound is during nerve blocks, injection treatments into the vocal cords, and voice/swallow assessments.
What are the potential side effects?
Potential side effects are not detailed but could include discomfort from the ultrasound procedure or any related interventions performed during the evaluation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and do not have any problems swallowing.
Select...
I am over 18 and do not have a cough.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am between 18 and 99 years old.
Select...
I have an open wound on my neck, including a tracheostomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately post-intervention and at 4 week follow-up visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post-intervention and at 4 week follow-up visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in volume of injectate in injection laryngoplasty measured by ultrasound compared to amount injected after procedure and at follow-up.
Evaluation of suprahyoid musculature on ultrasound for patients with muscle tension dysphonia.
Images and descriptors of internal branch of superior laryngeal nerve anatomy and normal variation.
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
6Treatment groups
Experimental Treatment
Group I: Vocal Cord ParesisExperimental Treatment1 Intervention
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 II: Vocal Cord ParalysisExperimental Treatment1 Intervention
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 III: Vocal Cord AtrophyExperimental Treatment1 Intervention
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 IV: DysphoniaExperimental Treatment1 Intervention
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 V: DysphagiaExperimental Treatment1 Intervention
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 VI: CoughExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,086 Previous Clinical Trials
1,147,147 Total Patients Enrolled
Anaïs Rameau, MDPrincipal InvestigatorWeill Medical College of Cornell University
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