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| ID | Type | Description | Link |
|---|---|---|---|
| A534100 | Other Identifier | UW Madison | |
| Protocol Version 10/22/25 | Other Identifier | UW Madison |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-ounce water swallow test | Diagnostic Test | Bedside water swallow dysphagia screen where vocal quality of the participant is assessed before and after swallowing 3 ounces of water | ||
| Kayser-Jones Brief Oral Health Status Examination (BOHSE) | Diagnostic Test | 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 | ||
| Tongue pressure | Diagnostic Test | 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 | ||
| Test of Masticating and Swallowing Solids (TOMASS) | Diagnostic Test | Measurement of bites, masticatory cycles, swallows, and time taken to consume a cracker | ||
| Respiratory function tests |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Older adults presenting to the emergency department
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael S Pulia, MD, PhD | Contact | 608-262-2908 | mpulia-lab@medicine.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael S Pulia, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Recruiting | Madison | Wisconsin | 53792 | United States |
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.
Beginning 9 months after publication of primary outcomes and ending 5 years after that date.
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.
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| ID | Term |
|---|---|
| D012129 | Respiratory Function Tests |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Saliva samples will be retained and human DNA sequences will not be collected from the saliva samples.
| Diagnostic Test |
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) |
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 |
| D010038 | Otorhinolaryngologic Diseases |