NCT06078527

Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
DEVICE	Cheung-Bearelly Aesthesiometer	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.
PROCEDURE	Transnasal Laryngoscopy	A procedure to examine your larynx (voice box)
OTHER	Questionnaires	Patient-reported health and behavioral outcomes measures will be administered

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-01-31
• Completion: 2028-01-31
• First posted: 2023-10-12
• Last updated: 2025-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study