Oral and Swallowing Function in Older Adults

NCT ID: NCT06368830

Last Updated: 2025-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-03

Study Completion Date

2026-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Oropharyngeal Dysphagia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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3-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

Intervention Type DIAGNOSTIC_TEST

Kayser-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

Intervention Type DIAGNOSTIC_TEST

Tongue 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

Intervention Type DIAGNOSTIC_TEST

Test of Masticating and Swallowing Solids (TOMASS)

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

Intervention Type DIAGNOSTIC_TEST

Respiratory 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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael S Pulia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael S Pulia, MD, PhD

Role: CONTACT

608-262-2908

Other Identifiers

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A534100

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 10/22/25

Identifier Type: OTHER

Identifier Source: secondary_id

2024-0337

Identifier Type: -

Identifier Source: org_study_id

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