Oral and Swallowing Function in Older Adults

Recruiting

• Conditions: Oropharyngeal Dysphagia

• Registration Number: NCT06368830
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Study Timeline

• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Study Start: 2024-06-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Wisconsin School of Medicine and Public Health; 🇺🇸 Madison, Wisconsin, United States