Oral and Swallowing Function in Older Adults

Characterizing Oral and Swallowing Function in Older Adults Presenting to the Emergency Department

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.

Study Overview

• Status: Recruiting
• Conditions: Oropharyngeal Dysphagia
• Intervention / Treatment: Diagnostic test: 3-ounce water swallow test; Diagnostic test: Kayser-Jones Brief Oral Health Status Examination (BOHSE); Diagnostic test: Tongue pressure; Diagnostic test: Test of Masticating and Swallowing Solids (TOMASS); Diagnostic test: Respiratory function tests

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Michael S Pulia, MD, PhD; Phone Number: 608-262-2908; Email: mpulia-lab@medicine.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University of Wisconsin School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Older adults presenting to the emergency department

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive oropharyngeal dysphagia screen prevalence	Number of participants with positive oropharyngeal dysphagia screen identified through bedside dysphagia screen and patient reported swallowing function	During emergency department visit, approximately 2-5 minutes for bedside dysphagia screen and 5-10 minutes for patient reported swallowing function

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean brief oral health status examination (BOHSE) score	Score 0 - 20 with 20 indicating the worst oral health	During emergency department visit, approximately 2-5 minutes
Oral dryness prevalence	Number of participants with stimulated salivary flow rate (volume saliva/collection time) less than two standard deviations below published norms	During emergency department visit, up to 10 minutes for saliva collection
Decreased tongue pressure prevalence	Number of participants with maximum isometric lingual pressures at front or back tongue location less than fifth percentile for published age-matched norms	During emergency department visit, approximately 2-5 minutes
Decreased masticatory function prevalence	Number of participants with test of masticating and swallowing solids (TOMASS) greater than two standard deviations above published age- and sex-matched norms for any of four components: number of bites, number of masticatory cycles, number of swallows, total time	During emergency department visit, approximately 2-5 minutes
pH of saliva sample	pH 0-14 of saliva as measured by digital pH meter	During emergency department visit, up to 10 minutes for saliva collection
Extensional viscosity of saliva sample	Extensional viscosity of saliva as measured by an extensional rheometer	During emergency department visit, up to 10 minutes for saliva collection
Salivary Substance P Concentration	Protein concentration (ng/mL) of Substance P in saliva	During emergency department visit, up to 10 minutes for saliva collection
Oral microbiome	Comparison of microbial community composition in buccal mucosa, tongue dorsum, and saliva based on oral and swallowing function	During emergency department visit, up to 10 minutes for saliva collection
Cell barrier function	Diffusion assays to quantify cell barrier function in bronchiole and blood vessel model after application of saliva to bronchiolar lumen	During emergency department visit, up to 10 minutes for saliva collection
Protein composition	Multiplex bead-based ELISA to identify concentration (ng/mL) of proteins in bronchiole and blood vessel model after application of saliva to bronchiolar lumen	During emergency department visit, up to 10 minutes for saliva collection
Gene expression	Quantification of gene expression in bronchiole and blood vessel model after application of saliva to bronchiolar lumen	During emergency department visit, up to 10 minutes for saliva collection
Immunofluorescent staining	Quantification of immunofluorescent staining in bronchiole and blood vessel model after application of saliva to bronchiolar lumen	During emergency department visit, up to 10 minutes for saliva collection
Immune cell trafficking	Quantification of immune cell trafficking in bronchiole and blood vessel model after application of saliva to bronchiolar lumen	During emergency department visit, up to 10 minutes for saliva collection

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Michael S Pulia, MD, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Respiratory Function Tests
• Other Study ID Numbers: 2024-0337; A534100 (Other Identifier: UW Madison); Protocol Version 10/22/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected during the study will be shared after deidentification to researchers whose proposed use of the data has been approved by principal investigator Dr. Michael Pulia.
• IPD Sharing Time Frame: Beginning 9 months after publication of primary outcomes and ending 5 years after that date.
• IPD Sharing Access Criteria: Proposals should be directed to Dr. Michael Pulia at mpulia-lab@medicine.wisc.edu. If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No