Oropharyngeal DysphagiaNCT06368830
Oral and Swallowing Function in Older Adults
An observational study of Oropharyngeal Dysphagia, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia
- What is being tested?
- 3-ounce water swallow test, Kayser-Jones Brief Oral Health Status Examination (BOHSE) and Tongue pressure
- Type of treatment
- Pill or oral medicine
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to 23 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Older adults presenting to the emergency department
Who may be able to join
- Age ≥ 60
- Clinically stable and able (not NPO) to safely drink water and eat a saltine cracker per ED provider
Who cannot join
- Prisoner
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792
About this study
Official title: Characterizing Oral and Swallowing Function in Older Adults Presenting to the Emergency Department
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.
Read the 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.
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- 3-ounce water swallow test, Kayser-Jones Brief Oral Health Status Examination (BOHSE), Tongue pressure, Test of Masticating and Swallowing Solids (TOMASS), Respiratory function tests
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-ounce water swallow testDiagnostic 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 pressureDiagnostic 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 testsDiagnostic 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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive oropharyngeal dysphagia screen prevalence
Number of participants with positive oropharyngeal dysphagia screen identified through bedside dysphagia screen and patient reported swallowing function
Measured: During emergency department visit, approximately 2-5 minutes for bedside dysphagia screen and 5-10 minutes for patient reported swallowing function
Secondary outcomes (13)
Mean brief oral health status examination (BOHSE) score
Score 0 - 20 with 20 indicating the worst oral health
Measured: During emergency department visit, approximately 2-5 minutes
Oral dryness prevalence
Number of participants with stimulated salivary flow rate (volume saliva/collection time) less than two standard deviations below published norms
Measured: 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
Measured: 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
Measured: During emergency department visit, approximately 2-5 minutes
pH of saliva sample
pH 0-14 of saliva as measured by digital pH meter
Measured: 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
Measured: During emergency department visit, up to 10 minutes for saliva collection
Salivary Substance P Concentration
Protein concentration (ng/mL) of Substance P in saliva
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During emergency department visit, up to 10 minutes for saliva collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start3 Jun 2024
- Primary completion23 Apr 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael S Pulia, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368830
- Sponsor's protocol ID
- 2024-0337
- Other IDs
- A534100, Protocol Version 10/22/25
- Status last verified
- Aug 2026
- First submitted
- 10 Apr 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Oral and Swallowing Function in Older Adults Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT06368830
- Acronym / sponsor ID
- 2024-0337
- Conditions
- Oropharyngeal Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults presenting to the emergency department
Key inclusion criteria (2 listed)
- Age ≥ 60
- Clinically stable and able (not NPO) to safely drink water and eat a saltine cracker per ED provider
Key exclusion criteria (2 listed)
- Prisoner
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-ounce water swallow testBedside water swallow dysphagia screen where vocal quality of the participant is assessed before and after swallowing 3 ounces of water | 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 | Diagnostic test | – |
| Tongue pressureMaximum 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 test | – |
| Test of Masticating and Swallowing Solids (TOMASS)Measurement of bites, masticatory cycles, swallows, and time taken to consume a cracker | Diagnostic test | – |
| Respiratory function testsParticipants 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) | Diagnostic test | – |
Primary outcome
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
13 secondary outcomes
Mean brief oral health status examination (BOHSE) score
Time frame: During emergency department visit, approximately 2-5 minutes
Oral dryness prevalence
Time frame: During emergency department visit, up to 10 minutes for saliva collection
Decreased tongue pressure prevalence
Time frame: During emergency department visit, approximately 2-5 minutes
Decreased masticatory function prevalence
Time frame: During emergency department visit, approximately 2-5 minutes
pH of saliva sample
Time frame: During emergency department visit, up to 10 minutes for saliva collection
Extensional viscosity of saliva sample
Time frame: During emergency department visit, up to 10 minutes for saliva collection
Salivary Substance P Concentration
Time frame: During emergency department visit, up to 10 minutes for saliva collection
Oral microbiome
Time frame: During emergency department visit, up to 10 minutes for saliva collection
Cell barrier function
Time frame: During emergency department visit, up to 10 minutes for saliva collection
Protein composition
Time frame: During emergency department visit, up to 10 minutes for saliva collection
Gene expression
Time frame: During emergency department visit, up to 10 minutes for saliva collection
Immunofluorescent staining
Time frame: During emergency department visit, up to 10 minutes for saliva collection
Immune cell trafficking
Time frame: During emergency department visit, up to 10 minutes for saliva collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Pulia, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Dysphagia, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.