Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06078527

Collaborator

National Spasmodic Dysphonia Association (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Presbylarynx Aspiration Spasmodic Dysphonia Globus Pharyngeus Larynx Paralysis Laryngeal Disease Vocal Cord Paralysis Iatrogenic Injury Sensory Neuropathy	Device: Cheung-Bearelly Aesthesiometer Procedure: Transnasal Laryngoscopy Other: Questionnaires	N/A

Detailed Description

PRIMARY OBJECTIVES:

Laryngeal sensation as measured by elicitation of laryngeal adductor reflex (LAR).
To compare the elicitation of laryngeal adductor reflex (LAR) threshold/probability to the Penetration-Aspiration Scale (PAS).

SECONDARY OBJECTIVES:

To assess patient-reported laryngeal sensation (PRLS) following stimulus and perceptual strength.
To assess laryngopharyngeal responses (e.g., cough, gag, swallow) following stimulus.
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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 30, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cancer Survivors 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.	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. Other Names: Aesthesiometer Procedure: Transnasal Laryngoscopy A procedure to examine your larynx (voice box) Other Names: Transnasal Flexible Laryngoscopy Other: Questionnaires Patient-reported health and behavioral outcomes measures will be administered

Arm

Intervention/Treatment

Experimental: Cancer Survivors

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.

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.

Other Names:

Aesthesiometer

Procedure: Transnasal Laryngoscopy

A procedure to examine your larynx (voice box)

Other Names:

Transnasal Flexible Laryngoscopy

Other: Questionnaires

Patient-reported health and behavioral outcomes measures will be administered

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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).