Laryngoscopy Assessment for Laryngopharyngeal Sensation Disorders

Overseen ByYue Ma, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-English speaking, Vocal fold immobility, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Transnasal Laryngoscopy for Laryngopharyngeal Sensation Disorders?

Research shows that laryngeal sensory testing, which can be done using a method similar to Transnasal Laryngoscopy, is effective in assessing and measuring sensory impairment in conditions like laryngopharyngeal reflux. This testing is safe, well-tolerated, and provides a quantifiable way to evaluate sensory function, which can help in understanding and treating sensation disorders.¹ ² ³ ⁴ ⁵

Is transnasal laryngoscopy safe for humans?

Transnasal laryngoscopy, also known as flexible endoscopic evaluation, is generally safe and well tolerated by patients, with studies showing it is safe in various conditions like laryngopharyngeal reflux and ALS.¹ ³ ⁶ ⁷ ⁸

How does transnasal laryngoscopy differ from other treatments for laryngopharyngeal sensation disorders?

Transnasal laryngoscopy is unique because it involves passing a video endoscope through the nose to assess the larynx, allowing for direct observation without the need for general anesthesia. This method is less invasive and can be performed with just local anesthesia, making it a safer and more comfortable option for patients.¹ ² ³ ⁹ ¹⁰

What is the purpose of this trial?

A previous study completed in 2022 (NCT05158179) was conducted using cohorts of healthy controls, and adults with general laryngopharyngeal disorders. This study will expand on the previous research to include a separate cohort of adults being seen in clinic for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments.

Research Team

Yue Ma, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

Ability and willingness to comply with study procedures

Ability to understand a written informed consent document, and the willingness to sign it

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

Exclusion Criteria

Known contraindication to any study-related procedure, or history of being unable to tolerate laryngoscopy

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

Doctors cannot examine my throat structures.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Visit Study Session

Participants attend a single 15-30 minute study session for questionnaires and laryngopharyngeal sensory testing

1 day

1 visit (in-person)

Follow-up

Participants' medical records are followed up for up to 2 years after the main study

Up to 2 years

Treatment Details

Interventions

Transnasal Laryngoscopy

Trial Overview 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.

Participant Groups

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.