Aspiration, Globus Pharyngeus, Iatrogenic Injury, Laryngeal Disease, Larynx Paralysis, Presbylarynx, Sensory Neuropathy, Spasmodic Dysphonia, Vocal Cord Paralysis
Conditions
Keywords
Cancer survivors, Previous cancer treatment, Laryngopharyngeal disorders
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).
Interventions
DEVICECheung-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.
PROCEDURETransnasal Laryngoscopy
A procedure to examine your larynx (voice box)
OTHERQuestionnaires
Patient-reported health and behavioral outcomes measures will be administered
Sponsors
University of California, San Francisco
National Spasmodic Dysphonia Association
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age \<=18 years. 2. 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 3. Ability and willingness to comply with study procedures. 4. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
1. Non-English speaking. 2. Laryngopharyngeal structures are not accessible on exam. 3. Known contraindication to any study-related procedure, or history of being unable to tolerate laryngoscopy. 4. Vocal fold immobility or severe hypomobility on adduction. 5. For head and neck cancer survivors only: Currently undergoing radiation therapy for head and neck cancer (i.e., primary/adjuvant radiation therapy treatment plan is not yet completed).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with triggered/positive laryngeal adduction response (LAR) | 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 |
| Median scores on the Penetration-Aspiration Scale (PAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median scores on the participant-reported laryngeal sensation (PRLS) | 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. |
| Percentage of participants with visualized laryngopharyngeal responses | 1 day | Percentage of participants with visualized laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus will be recorded by the clinician and reported. |
Countries
United States
Contacts
CONTACTYue Ma, MD
PRINCIPAL_INVESTIGATORYue Ma, MD
University of California, San Francisco
Outcome results
None listed