Brief Summary

The purpose of this research is to understand the normal function of swallowing and respiratory muscles in order to establish normal parameters. This will allow us to compare normal physiology and function of swallowing and breathing muscles to people with a medical history that would put them at risk for a swallowing problem. Our goal is to identify the best tests that can be quickly and easily administered to accurately detect swallowing impairment in adults. Involvement is limited to a single 2-hour evaluation.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

First Submitted

Initial submission to the registry

February 23, 2021

Completed

3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed

2 months until next milestone

Study Start

First participant enrolled

April 27, 2021

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2023

Completed

Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

2.4 years

First QC Date

February 23, 2021

Last Update Submit

January 12, 2024

Conditions

Dysphagia

Keywords

DysphagiaPeak Cough Flow (PCF)SwallowingRespiration

Outcome Measures

Primary Outcomes (4)

Penetration Aspiration Scale
Validated swallowing safety measurement that is an eight-point ordinal scale to indicate the depth of airway invasion during swallowing and the associated response. A minimum score of 1 would be no airway invasion, to a maximum score of 8 being airway invasion with no effort to expel the tracheal matter. Therefore, the lower the score, the better the outcome.
Baseline
Yale Residue Severity Rating Scale
Validated measure of swallowing efficiency using a validated anatomically defined and image-based assessment of post-swallow pharyngeal residue severity. Clinical uses include accurate classification of vallecula and pyriform sinus residue severity patterns as none, trace, mild, moderate, or severe for diagnostic purposes, determination of functional therapeutic change, and precise dissemination of shared information.
Baseline
Vocal Fold Mobility Impairment
During a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), the vocal folds will be visualized using a small camera passed through the open nasal passage. The patient will be asked to make a series of vocal tasks so that we can visualize their movement, any immobility will be notated.
Baseline
Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)
5-point ordinal scale used to rate both the safety and efficiency of swallowing trials. For efficiency, the minimal score of 0 means residue is less than 10%, the maximal score of 4 means there is more than 90% of residue across trials. For safety a minimal score of 0 means no airway invasion, and a maximal score of 4 means there was chronic and gross amounts of food or liquids that were aspirated. Therefore, the lower the scores, the better the outcomes.
Baseline

Study Arms (2)

Healthy adults

132 individuals with no history of swallowing impairment or any health conditions known to impact swallowing function will be included in this study to serve as a comparative control group or reference standard group here and in future studies.

Procedure: Fiberoptic Endoscopic Evaluation of SwallowingProcedure: Videofluoroscopic Swallowing StudyProcedure: Voluntary Peak Cough Flow TestingProcedure: Iowa Oral Performance InstrumentProcedure: Capsaicin ChallengeProcedure: Pulmonary Function TestingOther: Voicing Tasks

Adults at risk for swallowing impairment.

132 individuals with an underlying condition documented to lead to dysphagia will be enrolled in this study. 2) Confirmed medical diagnosis associated with an increased risk of dysphagia including but are not limited to: head and neck cancer, neurologic (e.g., stroke, traumatic brain impairment), neurodegenerative (e.g., Parkinson's disease, amyotrophic lateral sclerosis), neuromuscular disorders (e.g., myotonic dystrophy, Pompe disease, inclusion body myositis) rheumatologic diseases (e.g., dermatomyositis, inclusion body myositis, scleroderma), chronic respiratory illnesses (e.g., chronic obstructive pulmonary disease), structural (e.g., mass or trauma to the upper aerodigestive tract) and iatrogenic conditions (e.g., post-surgical such as anterior cervical discectomy/fusion or cardiac, post-radiation treatment to the upper aerodigestive tract).

Interventions

Fiberoptic Endoscopic Evaluation of SwallowingPROCEDURE

This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.

Also known as: (FEES)