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NCT Number: NCT06368830

Oral and Swallowing Function in Older Adults

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.

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Key information

Conditions

Oropharyngeal Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

Primary outcomes

  1. 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

  1. Mean brief oral health status examination (BOHSE) score

    Time frame: During emergency department visit, approximately 2-5 minutes

    Score 0 - 20 with 20 indicating the worst oral health

  2. Oral dryness prevalence

    Time frame: 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

  3. Decreased tongue pressure prevalence

    Time frame: 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

  4. Decreased masticatory function prevalence

    Time frame: 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

  5. pH of saliva sample

    Time frame: During emergency department visit, up to 10 minutes for saliva collection

    pH 0-14 of saliva as measured by digital pH meter

  6. Extensional viscosity of saliva sample

    Time frame: During emergency department visit, up to 10 minutes for saliva collection

    Extensional viscosity of saliva as measured by an extensional rheometer

  7. Salivary Substance P Concentration

    Time frame: During emergency department visit, up to 10 minutes for saliva collection

    Protein concentration (ng/mL) of Substance P in saliva

  8. Oral microbiome

    Time frame: 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

  9. Cell barrier function

    Time frame: 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

  10. Protein composition

    Time frame: 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

  11. Gene expression

    Time frame: 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

  12. Immunofluorescent staining

    Time frame: 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

  13. Immune cell trafficking

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Michael S Pulia, MD, PhD

CONTACT

[email protected]

608-262-2908

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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