Oral and Swallowing Function in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3-ounce water swallow test, Kayser-Jones Brief Oral Health Status Examination (BOHSE), Tongue pressure, Test of Masticating and Swallowing Solids (TOMASS).
- Who it may be relevant to
- Registry conditions: Oropharyngeal Dysphagia. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterizing Oral and Swallowing Function in Older Adults Presenting to the Emergency Department
Overview
The purpose of this study is to learn about oral and swallowing function in older adults presenting to the emergency department. The hypothesis is that older adults often have problems with oral and swallowing function and these problems relate to other conditions. Study activities are done during the emergency department visit and include providing saliva samples, completing a bedside water swallow test, completing oral function assessments, completing respiratory function tests, and answering survey questions.
Detailed description
Oropharyngeal dysphagia is characterized by changes in swallow event timing, biomechanics, and pressure generation that occur with advancing age resulting in aspiration of bacteria-laden saliva, food, and liquid into the lungs. Currently, oral and swallowing function is not routinely or comprehensively assessed in older adults despite poor oral health and oropharyngeal dysphagia being known risk factors for pneumonia, the leading infectious cause of mortality among adults 65+. This study seeks to extensively characterize oral and swallowing function in older adults presenting to the emergency department to clarify the relationship of oral hypofunction, dysphagia, and the upper airway microbiome. To achieve this aim, study procedures include a bedside dysphagia screen, oral health assessment, tongue pressure measurement, masticatory function assessment, respiratory function tests, salivary compositional analysis, oral microbiome analysis, and microphysiological system analysis which applies saliva samples to a bronchiolar lumen model to mimic aspiration and quantify cellular and tissue responses to the saliva microbiome and secreted mediators.
Per amendment approved 10/29/2025: Saliva samples for microbiota analysis will not be collected from participants enrolled after 10/22/2025.
Interventions
- Diagnostic test 3-ounce water swallow test
Bedside water swallow dysphagia screen where vocal quality of the participant is assessed before and after swallowing 3 ounces of water - Diagnostic test Kayser-Jones Brief Oral Health Status Examination (BOHSE)
Scored assessment of the lymph nodes, lips, tongue, tissue inside of cheek, floor and roof of mouth, gums between teeth and/or under artificial teeth, saliva, condition of natural/artificial teeth, chewing position of teeth, and oral cleanliness - Diagnostic test Tongue pressure
Maximum isometric lingual pressure at the front and back of tongue will be measured by placing an air-filled pressure bulb on the surface of the oral tongue and having participants press the bulb "as hard as possible" against the hard palate - Diagnostic test Test of Masticating and Swallowing Solids (TOMASS)
Measurement of bites, masticatory cycles, swallows, and time taken to consume a cracker - Diagnostic test Respiratory function tests
Participants will take a maximum inhalation and forcefully exhale into a spirometer to measure maximum expiratory pressure (MEP), fully exhale their air and take a maximal inhalation into the spirometer to measure maximum inspiratory pressure (MIP), and produce a single strong cough into to spirometer to measure peak expiratory flow (PEF) and forced expiratory volume (FEV1)
Primary outcome measures
- Positive oropharyngeal dysphagia screen prevalence [Time frame: During emergency department visit, approximately 2-5 minutes for bedside dysphagia screen and 5-10 minutes for patient reported swallowing function]
Secondary outcome measures (12)
- Mean brief oral health status examination (BOHSE) score [Time frame: During emergency department visit, approximately 2-5 minutes]
- Oral dryness prevalence [Time frame: During emergency department visit, up to 10 minutes for saliva collection]
- Decreased tongue pressure prevalence [Time frame: During emergency department visit, approximately 2-5 minutes]
- Decreased masticatory function prevalence [Time frame: During emergency department visit, approximately 2-5 minutes]
- pH of saliva sample [Time frame: During emergency department visit, up to 10 minutes for saliva collection]
- Extensional viscosity of saliva sample [Time frame: During emergency department visit, up to 10 minutes for saliva collection]
- Salivary Substance P Concentration [Time frame: During emergency department visit, up to 10 minutes for saliva collection]
- Oral microbiome [Time frame: During emergency department visit, up to 10 minutes for saliva collection]
- Cell barrier function [Time frame: During emergency department visit, up to 10 minutes for saliva collection]
- Protein composition [Time frame: During emergency department visit, up to 10 minutes for saliva collection]
- Gene expression [Time frame: During emergency department visit, up to 10 minutes for saliva collection]
- Immunofluorescent staining [Time frame: During emergency department visit, up to 10 minutes for saliva collection]
Eligibility criteria
Inclusion criteria
- Age ≥ 60
- Clinically stable and able (not NPO) to safely drink water and eat a saltine cracker per ED provider
Exclusion criteria
- Prisoner
- Non-English speaking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Wisconsin School of Medicine and Public Health — Madison
Identifiers
NCT: NCT06368830 · 2024-0337 · A534100 · Protocol Version 10/22/25