Study Results
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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RECRUITING
200 participants
OBSERVATIONAL
2024-06-03
2026-05-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
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
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
Test of Masticating and Swallowing Solids (TOMASS)
Measurement of bites, masticatory cycles, swallows, and time taken to consume a cracker
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)
Eligibility Criteria
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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
60 Years
ALL
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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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
Countries
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Central Contacts
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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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