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Procedure

Laryngoscopy Assessment for Laryngopharyngeal Sensation Disorders

N/A

Waitlist Available

Led By Yue Ma, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age <=18 years

Individuals without a laryngopharyngeal disorder (health controls) or with a laryngopharyngeal disorder. Laryngopharyngeal disorder includes but is not limited to: presbylarynx, aspiration; spasmodic dysphonia; globus pharynges; vocal fold paralysis; iatrogenic injury to the larynx; muscle tension dysphonia; neurogenic dysphagia; laryngeal sensory neuropathy; and laryngopharyngeal disorders resulting from prior radiation therapy in individuals with a history of head and neck cancer who have completed radiation therapy as primary or adjuvant cancer treatment

Must not have

For head and neck cancer survivors only: Currently undergoing radiation therapy for head and neck cancer (i.e., primary/adjuvant radiation therapy treatment plan is not yet completed)

Non-English speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

No Placebo-Only Group

Summary

This trial will study laryngopharyngeal disorders caused by cancer treatment, building on previous research.

Who is the study for?

This trial is for adults who can follow study procedures and understand/sign consent forms. It's open to those with or without laryngopharyngeal disorders, including conditions like voice box muscle issues, swallowing difficulties, and nerve damage. Cancer survivors must have finished radiation therapy but cannot join if they're non-English speakers, their throat structures aren't examinable, have severe vocal cord issues, are still in cancer treatment, or can't tolerate laryngoscopy.

What is being tested?

The study tests how well the throat works in people with hoarseness and related conditions after cancer treatments. It uses a special scope to look inside the throat (Transnasal Laryngoscopy), a device measuring sensation (Cheung-Bearelly Aesthesiometer), and questionnaires to gather patient-reported outcomes.

What are the potential side effects?

Possible side effects include discomfort from the transnasal laryngoscopy procedure such as gagging or nosebleeds; there may also be temporary soreness or irritation in the throat area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or younger.

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I either have no throat disorders or I have a condition affecting my throat or voice.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving radiation therapy for my head or neck cancer.

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I do not speak English.

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Doctors cannot examine my throat structures.

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My vocal cords don't move well or at all when I try to speak.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median scores on the Penetration-Aspiration Scale (PAS)

Percentage of participants with triggered/positive laryngeal adduction response (LAR)

Secondary study objectives

Median scores on the participant-reported laryngeal sensation (PRLS)

Percentage of participants with visualized laryngopharyngeal responses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cancer SurvivorsExperimental Treatment3 Interventions

Participants will attend a single 15-30 minute study session during which they will answer questionnaires (5-10 minutes) and undergo laryngopharyngeal sensory testing (10-20 minutes). There will be up to 2 years of medical record follow up after completing the main study.

0 / 6Eligibility criteria met