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NCT06078527 | NOT YET RECRUITING | Presbylarynx

Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort
Sponsor:

University of California, San Francisco

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

Presbylarynx

Aspiration

Spasmodic Dysphonia

Globus Pharyngeus

Larynx Paralysis

Laryngeal Disease

Vocal Cord Paralysis

Iatrogenic Injury

Sensory Neuropathy

Intervention/treatment

Cheung-Bearelly Aesthesiometer

Transnasal Laryngoscopy

Questionnaires

Phase

NA

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : DEVICE_FEASIBILITY
Official Title : Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders
Actual Study Start Date : 2025-02-01
Estimated Primary Completion Date : 2026-09-30
Estimated Study Completion Date : 2026-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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).
Assessment of Laryngopharyngeal Sensation: Cancer Survivor Cohort

Location Details

NCT06078527

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How to Participate

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Locations

Not yet recruiting

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143