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Oral and Swallowing Function in Older Adults

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06368830
Enrollment
111
Registered
2024-04-16
Start date
2024-06-03
Completion date
2026-04-23
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Dysphagia

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.

Interventions

DIAGNOSTIC_TEST3-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_TESTKayser-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_TESTTongue 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_TESTTest of Masticating and Swallowing Solids (TOMASS)

Measurement of bites, masticatory cycles, swallows, and time taken to consume a cracker

DIAGNOSTIC_TESTRespiratory 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)

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Positive oropharyngeal dysphagia screen prevalenceDuring emergency department visit, approximately 2-5 minutes for bedside dysphagia screen and 5-10 minutes for patient reported swallowing functionNumber of participants with positive oropharyngeal dysphagia screen identified through bedside dysphagia screen and patient reported swallowing function

Secondary

MeasureTime frameDescription
Mean brief oral health status examination (BOHSE) scoreDuring emergency department visit, approximately 2-5 minutesScore 0 - 20 with 20 indicating the worst oral health
Oral dryness prevalenceDuring emergency department visit, up to 10 minutes for saliva collectionNumber of participants with stimulated salivary flow rate (volume saliva/collection time) less than two standard deviations below published norms
Decreased tongue pressure prevalenceDuring emergency department visit, approximately 2-5 minutesNumber 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 prevalenceDuring emergency department visit, approximately 2-5 minutesNumber 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 sampleDuring emergency department visit, up to 10 minutes for saliva collectionpH 0-14 of saliva as measured by digital pH meter
Extensional viscosity of saliva sampleDuring emergency department visit, up to 10 minutes for saliva collectionExtensional viscosity of saliva as measured by an extensional rheometer
Salivary Substance P ConcentrationDuring emergency department visit, up to 10 minutes for saliva collectionProtein concentration (ng/mL) of Substance P in saliva
Oral microbiomeDuring emergency department visit, up to 10 minutes for saliva collectionComparison of microbial community composition in buccal mucosa, tongue dorsum, and saliva based on oral and swallowing function
Cell barrier functionDuring emergency department visit, up to 10 minutes for saliva collectionDiffusion assays to quantify cell barrier function in bronchiole and blood vessel model after application of saliva to bronchiolar lumen
Protein compositionDuring emergency department visit, up to 10 minutes for saliva collectionMultiplex bead-based ELISA to identify concentration (ng/mL) of proteins in bronchiole and blood vessel model after application of saliva to bronchiolar lumen
Gene expressionDuring emergency department visit, up to 10 minutes for saliva collectionQuantification of gene expression in bronchiole and blood vessel model after application of saliva to bronchiolar lumen
Immunofluorescent stainingDuring emergency department visit, up to 10 minutes for saliva collectionQuantification of immunofluorescent staining in bronchiole and blood vessel model after application of saliva to bronchiolar lumen
Immune cell traffickingDuring emergency department visit, up to 10 minutes for saliva collectionQuantification of immune cell trafficking in bronchiole and blood vessel model after application of saliva to bronchiolar lumen

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMichael S Pulia, MD, PhD

University of Wisconsin, Madison

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026