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Clinical Trial 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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06078527
Study type Interventional
Source University of California, San Francisco
Contact James Lappin, Jr.
Phone 877-827-3222
Email james.lappin@ucsf.edu
Status Not yet recruiting
Phase N/A
Start date August 1, 2024
Completion date March 31, 2026

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