Aspiration Clinical Trial
Official title:
Assessment of Laryngopharyngeal Sensation in Patients With Laryngopharyngeal Disorders
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | March 31, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Spasmodic Dysphonia Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04083677 -
Routine Point of Care Ultrasound (POCUS) Assessment of Antral Gastric Contents in Traumatic Surgical Patients for Prevention of Aspiration Pneumonitis
|
||
Terminated |
NCT05101668 -
Safety and Efficacy of Intracranial Thrombus Aspiration Catheter in the Treatment of Acute Large-vessel Occlusive Stroke
|
N/A | |
Completed |
NCT02588495 -
Accuracy of Gastric Ultrasound to Diagnose a "Full Stomach". A Bayesian Framework
|
N/A | |
Completed |
NCT02576756 -
Retrospective Study in Patients Who Have Had a Difficult Intubation.
|
N/A | |
Completed |
NCT01777672 -
Effect of Afferent Oropharyngeal Pharmacological and Electrical Stimulation on Swallow Response and on Activation of Human Cortex in Stroke Patients With Oropharyngeal Dysphagia
|
Phase 2 | |
Completed |
NCT05033041 -
Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide
|
Phase 4 | |
Recruiting |
NCT05079620 -
Early Antibiotics After Aspiration in ICU Patients
|
Phase 4 | |
Completed |
NCT01011803 -
Correlation of Phonation With Deglutition and Aspiration Risk in the ICU Patients - an Exploratory Study
|
N/A | |
Recruiting |
NCT06137976 -
Surgeon Perception of Gastric Decompression at Time of Gynecologic Laparoscopy
|
N/A | |
Completed |
NCT04645043 -
Ultrasound Guided Esophageal Pressure
|
N/A | |
Completed |
NCT01807884 -
Comparison of Two Strategies of Oropharyngeal and Tracheal Suctioning in Mechanically Ventilated Patients
|
N/A | |
Completed |
NCT03555604 -
Evaluation of the Effect of Body Mass Index on Gastric Volume With Ultrasound in Term Pregnant Women
|
||
Completed |
NCT03573609 -
Evaluation of the Effectiveness and Safety of Supratube Device
|
N/A | |
Enrolling by invitation |
NCT04411290 -
Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases
|
||
Completed |
NCT05734937 -
Ultrasound Evaluation of Gastric Volume in Pediatric Patients Undergoing Adenotonsillectomy Surgery
|
N/A | |
Recruiting |
NCT05330351 -
Gastric Ultrasound in Pediatric Trauma Patients
|
||
Terminated |
NCT02437513 -
NewBreez for Airway Protection in Head and Neck Cancer Patients With Chronic Aspiration
|
N/A | |
Completed |
NCT04786691 -
How do You Take Your Coffee Before Anesthesia
|
N/A | |
Completed |
NCT05434442 -
Caregivers Tracheal Aspiration Training
|
N/A | |
Completed |
NCT03305757 -
Seroma Reduction After Mastectomy
|
Phase 4 |