Skip to main content
Clinical Trials/NCT06368830
NCT06368830
Recruiting
Not Applicable

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

University of Wisconsin, Madison1 site in 1 country200 target enrollmentJune 3, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oropharyngeal Dysphagia
Sponsor
University of Wisconsin, Madison
Enrollment
200
Locations
1
Primary Endpoint
Positive oropharyngeal dysphagia screen prevalence
Status
Recruiting
Last Updated
5 months ago

Overview

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. Per amendment approved 10/29/2025: Saliva samples for microbiota analysis will not be collected from participants enrolled after 10/22/2025.

Registry
clinicaltrials.gov
Start Date
June 3, 2024
End Date
May 1, 2026
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Clinically stable and able (not NPO) to safely drink water and eat a saltine cracker per ED provider

Exclusion Criteria

  • Non-English speaking

Outcomes

Primary Outcomes

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

Number of participants with positive oropharyngeal dysphagia screen identified through bedside dysphagia screen and patient reported swallowing function

Secondary Outcomes

  • Oral microbiome(During emergency department visit, up to 10 minutes for saliva collection)
  • Cell barrier function(During emergency department visit, up to 10 minutes for saliva collection)
  • Protein composition(During emergency department visit, up to 10 minutes for saliva collection)
  • Gene expression(During emergency department visit, up to 10 minutes for saliva collection)
  • Immune cell trafficking(During emergency department visit, up to 10 minutes for saliva collection)
  • Oral dryness prevalence(During emergency department visit, up to 10 minutes for saliva collection)
  • Decreased tongue pressure prevalence(During emergency department visit, approximately 2-5 minutes)
  • Decreased masticatory function prevalence(During emergency department visit, approximately 2-5 minutes)
  • pH of saliva sample(During emergency department visit, up to 10 minutes for saliva collection)
  • Immunofluorescent staining(During emergency department visit, up to 10 minutes for saliva collection)
  • Mean brief oral health status examination (BOHSE) score(During emergency department visit, approximately 2-5 minutes)
  • Salivary Substance P Concentration(During emergency department visit, up to 10 minutes for saliva collection)
  • Extensional viscosity of saliva sample(During emergency department visit, up to 10 minutes for saliva collection)

Study Sites (1)

Loading locations...

Similar Trials