Laryngoscopy Assessment for Laryngopharyngeal Sensation Disorders

Overseen By Yue 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about throat and voice disorders in individuals who have undergone cancer treatments like radiation. Researchers will use transnasal laryngoscopy—a procedure that examines the throat with a thin, flexible tube inserted through the nose—to assess throat sensations and gather participant information. The trial is open to those with a history of head and neck cancer who have completed radiation therapy, as well as individuals with other throat issues or no throat disorders. Participants will attend a short study session and may have their medical records monitored for up to two years. Ideal candidates are those who have completed cancer treatment and experience unusual throat symptoms. As an unphased trial, this study offers a unique opportunity to contribute to understanding throat health after cancer treatment.

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 prior data suggests that transnasal laryngoscopy is safe for assessing laryngopharyngeal sensation disorders?

Research shows that transnasal laryngoscopy is a safe procedure. Doctors have successfully used it in patients with various conditions, including severe throat muscle problems, without major safety concerns. Studies have found that patients tolerate it well, even those with complex health issues. Reports of significant side effects are absent, making it a reliable option for examining throat and voice box conditions. This procedure involves using a thin, flexible tube through the nose to examine the throat, and it has proven safe in outpatient settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transnasal laryngoscopy for assessing laryngopharyngeal sensation disorders because it offers a less invasive and more accessible way to evaluate these conditions. Unlike traditional methods, which might involve more discomfort or complicated procedures, transnasal laryngoscopy is performed through the nose, making it simpler and potentially more comfortable for patients. Additionally, this method allows for quick assessments, typically taking just 10–20 minutes, and can be easily integrated into routine clinical practice. The study aims to find out how well this technique can help in diagnosing sensation disorders, particularly in cancer survivors, which could lead to improved patient care and outcomes.

What evidence suggests that transnasal laryngoscopy is effective for assessing laryngopharyngeal sensation disorders?

Research shows that transnasal laryngoscopy effectively checks problems in the throat and nearby areas. It accurately identifies conditions like laryngopharyngeal reflux, where stomach acid flows back and affects the throat. Studies have found it safe, easy for patients to handle, and reliable. This trial will use transnasal laryngoscopy to examine throat issues, especially in cancer survivors who may have had treatments affecting their throat. ^{6 7 8 9 10}

Who Is on the Research Team?

Yue Ma, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Cancer Survivors Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Spasmodic Dysphonia Association

Collaborator

Trials

3

Recruited

60+

National Spasmodic Dysphonia Association

Collaborator

Trials

2

Recruited

50+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9895211/

The Efficacy of Transnasal Esophagoscopy in ... TNE is an efficient tool for evaluating LPR in Thai patients. The procedure was proven to be safe, well tolerated, and highly satisfied.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8305729/

Value of Transnasal Esophagoscopy in the Workup ... Results: In the investigation of LPR, TNE showed a sensitivity, specificity and accuracy of 96%, 85% and 95%, respectively. The most common ...

3. researchgate.net researchgate.net/publication/8160520_Evaluating_the_effectiveness_and_efficiency_of_voice_therapy_using_transnasal_flexible_laryngoscopy_A_randomized_controlled_trial

Evaluating the effectiveness and efficiency of voice therapy ... Evaluating the effectiveness and efficiency of voice therapy using transnasal flexible laryngoscopy: A randomized controlled trial. December ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0385814621000419

Questionnaire survey on pharyngolaryngeal sensation ... The essential swallowing sensations of mechanical stimulation, chemical stimulation, thermal stimulation were 84.9%, 5.4%, and 9.7%, respectively. The frequency ...

5. researchgate.net researchgate.net/publication/330027814_Clinical_outcomes_of_laryngopharyngeal_reflux_treatment_A_systematic_review_and_meta-analysis

Clinical outcomes of laryngopharyngeal reflux treatment Clinical outcomes of laryngopharyngeal reflux treatment: A systematic review and meta‐analysis. Wiley. The Laryngoscope. December 2018; 129(5):1174-1187.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19852871/

Laryngeal sensory testing in the assessment of patients ... Laryngeal sensory testing gives a quantifiable means of assessment in patients with laryngopharyngeal reflux, and can be used to measure the response to ...

7. emjreviews.com emjreviews.com/neurology/article/patterns-of-laryngeal-changes-on-clinical-application-of-mechanical-insufflation-exsufflation-seen-with-transnasal-laryngoscopy-for-patients-with-varied-neurological-conditions-and-bulbar-j110124/

Patterns of Laryngeal Changes on Clinical Application ... The work has proven safety in transnasal laryngoscopy for patients with bulbar onset and more severe bulbar impairment with an attempt to ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06078527

Assessment of Laryngopharyngeal Sensation: Cancer ... To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength. II. To assess laryngopharyngeal responses (e.g., cough, gag, ...

9. researchgate.net researchgate.net/publication/10963116_The_Safety_of_Flexible_Endoscopic_Evaluation_of_Swallowing_With_Sensory_Testing_in_an_Outpatient_Otolaryngology_Setting

The Safety of Flexible Endoscopic Evaluation ... To study the safety of flexible endoscopic evaluation of swallowing with sensory testing in a private otolaryngology office setting.

10. sciencedirect.com sciencedirect.com/science/article/pii/S0002934399003381

Clinical assessment of pharyngolaryngeal sensitivity The purpose of this article is to review the ongoing clinical research on assessment of laryngeal and pharyngeal sensitivity