Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR). II. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS). SECONDARY OBJECTIVES: I. To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength. II. To assess laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus. III. To assess patient reported outcomes (PROs). EXPLORATORY OBJECTIVES: I. To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to: modified barium swallow (MBS) study kinematics; MBS Dynamic Imaging Grade of Swallowing Toxicity (MBS DIGEST); MD Anderson Dysphagia Inventory patient reported outcomes measure (MDADI PROMs); Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing (DIGEST-FEES) Flexible Endoscopic Evaluation of Swallowing Visual Analysis of Swallowing Efficiency and Safety (FEES VASES). OUTLINE: Participants receiving care at University of California, San Francisco (UCSF) for an existing laryngopharyngeal disorder resulting from previous radiation or other cancer treatments will undergo laryngopharyngeal sensory testing at a single visit. There will be up to 2 years of medical record follow up after completing the main study. Data collected from this separate cohort may be compared with historical data collected in a previous study (NCT05158179).

Official Title
-----------------
Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders

Conditions
-----------------
Presbylarynx, Aspiration, Spasmodic Dysphonia, Globus Pharyngeus, Larynx Paralysis, Laryngeal Disease, Vocal Cord Paralysis, Iatrogenic Injury, Sensory Neuropathy

Intervention / Treatment
-----------------
* Device: Cheung-Bearelly Aesthesiometer
* Procedure: Transnasal Laryngoscopy
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Ability and willingness to comply with study procedures. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: Non-English speaking. Laryngopharyngeal structures are not accessible on exam. Known contraindication to any study-related procedure, or history of being unable to tolerate laryngoscopy. Vocal fold immobility or severe hypomobility on adduction. 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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cancer Survivors<br>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. | Device: Cheung-Bearelly Aesthesiometer<br>* The Cheung-Bearelly Aesthesiometer will be used to deliver a range of calibrated stimuli through the channeled flexible laryngoscope to assess sensation of the laryngopharynx.<br>* Other names: Aesthesiometer;Procedure: Transnasal Laryngoscopy<br>* A procedure to examine your larynx (voice box)<br>* Other names: Transnasal Flexible Laryngoscopy;Other: Questionnaires<br>* Patient-reported health and behavioral outcomes measures will be administered<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with triggered/positive laryngeal adduction response (LAR) | Elicitation of LAR is defined as a unilateral or bilateral laryngeal adduction immediately following laryngeal stimulus through frame-by-frame analysis of video recordings (visualized on laryngoscopy). An acceptable tactile stimulus is near orthogonal (less than 30 degrees deviation) to the mucosal surface and unobstructed by salivary forces. The percentage of participants with LAR will be reported | 1 day | 
| Median scores on the Penetration-Aspiration Scale (PAS) | The PAS is a widely-used ordinal scale metric used to describe severity of aspiration. The PAS score is multidimensional, i.e., include several observations within each score: (1) depth of airway invasion (material above, contacting, or below the level of vocal folds; (2) whether or not there is material remaining after the swallow (ejected, not ejected); and (3) the patient's response to material present in the airway (effort to clear the material). The PAS is an 8-point ordinal scale, with a total score ranging from 1 representing the least and 8 representing the highest or most severe score. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median scores on the participant-reported laryngeal sensation (PRLS) | The PRLS is defined as a binary response to participants' self-reported detection of laryngeal stimulation. Once the participant indicates they perceived the stimulus, the research team will ask the participant to provide a perceptual strength rating on a 1-10 scale, with higher scores indicated a greater strength of stimulus. | 1 day | 
| Percentage of participants with visualized laryngopharyngeal responses | Percentage of participants with visualized laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus will be recorded by the clinician and reported. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer survivors, Previous cancer treatment, Laryngopharyngeal disorders