Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT06078527
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).
Study:
NCT06078527
Study Brief:
Protocol Section:
NCT06078527