NCT06368830

Oral and Swallowing Function in Older Adults

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Oropharyngeal Dysphagia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-06-03
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-04-16
• Last updated: 2025-11-05

Locations

1 site across 1 country: United States