University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT06078527
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
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:
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Aesthesiometer
A procedure to examine your larynx (voice box)
Other names: Transnasal Flexible Laryngoscopy
Patient-reported health and behavioral outcomes measures will be administered
Time frame: 1 day
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
Time frame: 1 day
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.
Time frame: 1 day
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.
Time frame: 1 day
Percentage of participants with visualized laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus will be recorded by the clinician and reported.
Contact information is provided by the study sponsor or research team.
University of California, San Francisco
Other
Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04764604
Cranial Nerve Diseases, Dysphonia
London, United Kingdom
View Trial DetailsNCT03749863
Atrophy, Atrophy; Larynx
Los Angeles, California, United States
View Trial DetailsNCT03702322
Age-related Dysphonia, Presbylarynx
Scottsdale, Arizona, United States
View Trial DetailsNCT03557775
Presbylarynx
Charleston, South Carolina, United States
View Trial Details