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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-10667 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| National Spasmodic Dysphonia Association | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer Survivors | Experimental | Participants will attend a single 15-30 minute study session during which they will answer questionnaires (5-10 minutes) and undergo laryngopharyngeal sensory testing (10-20 minutes). There will be up to 2 years of medical record follow up after completing the main study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cheung-Bearelly Aesthesiometer | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yue Ma, MD | Contact | 877-827-3222 | cancertrials@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yue Ma, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| Transnasal Laryngoscopy | Procedure | A procedure to examine your larynx (voice box) |
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| Questionnaires | Other | Patient-reported health and behavioral outcomes measures will be administered |
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| 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. | 1 day |
| ID | Term |
|---|---|
| D055154 | Dysphonia |
| D000079564 | Globus Sensation |
| D014826 | Vocal Cord Paralysis |
| D007818 | Laryngeal Diseases |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003291 | Conversion Disorder |
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
| D020421 | Vagus Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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