Oral and Swallowing Function in Older Adults

University of Wisconsin (UW)

Status: Enrolling

Conditions: Oropharyngeal Dysphagia

Treatments: Diagnostic Test: Kayser-Jones Brief Oral Health Status Examination (BOHSE); Diagnostic Test: 3-ounce water swallow test; Diagnostic Test: Tongue pressure; Diagnostic Test: Test of Masticating and Swallowing Solids (TOMASS); Diagnostic Test: Respiratory function tests

Study type: Observational

Funder types: Other

Identifiers

NCT06368830

A534100 (Other Identifier)

Protocol Version 10/22/25 (Other Identifier)

2024-0337

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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