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.
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.
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.
Single group
Cheung-Bearelly Aesthesiometer
DeviceThe Cheung-Bearelly Aesthesiometer will be used to deliver a range of calibrated stimuli through the channeled flexible laryngoscope to assess sensation of the laryngopharynx.
Transnasal Laryngoscopy
Procedure/SurgeryA procedure to examine your larynx (voice box)
Questionnaires
Other interventionPatient-reported health and behavioral outcomes measures will be administered
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
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.
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.
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.
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Spasmodic Dysphonia Association
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
