DysphagiaNCT04569097
Novel Pharyngeal Metrics to Predict Dysphagia Outcomes
A study of Dysphagia and Swallowing Disorders, run by VA Office of Research and Development at 3 sites in United States.
Trial summary
This multi-site trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Swallowing Disorders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 227 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jun 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed an informed consent form
- Receive a dysphagia diagnosis by a speech-language pathologist
- Must have a dysphagia treatment plan with the goal of strengthening the oropharyngeal musculature
- English speaking
Who cannot join
- history of allergic response to barium
- history of allergic response to topical anesthetics
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220-2213
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254
About this study
Official title: Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry
This multi-site trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. A non-dysphagic Veteran control group will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to non-dysphagic controls using manometry, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.
The investigators aim to 1) quantify change in pressure measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pressure-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.
Read the detailed description
This multi-center trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 6-4 weeks post-treatment, and 8 weeks post-treatment. A non-dysphagic Veteran control group (n=50) will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to nondysphagic controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient reported outcome measures. The investigators aim to 1) quantify change in pHRM measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pHRM-based metrics best track with patient-reported outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.
- Conditions
- Dysphagia, Swallowing Disorders
- Being tested
- standard of care lingual strengthening
- Keywords
- dysphagia, manometry, swallowing, veterans
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of care lingual strengtheningOther
standard or care lingual strengthening approaches with outcome measured with novel pressure metrics
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Experimental | lingual strengthening Receives: Other: standard of care lingual strengthening |
| Controls | No intervention | No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program |
What is being measured
The primary outcome is the main question the study is designed to answer.
pHRM Pressure Change (Pharyngeal)
Will assess the change in pressure by pharyngeal high resolution manometry over the time frame. The primary measure of interest is Integral Pressure during the 10 mL swallow at the tongue base. This is measured in two forms:
- Pharyngeal Contractile Integral (PhCI): range is between 100 and 600 mmHg·s·cm ; 2. Mesopharyngeal Max Pressure (tongue base): range is between ~115-210 mmHg in healthy adults. Positive change would be a movement toward normal range of pressure. This metric is measured automatically in both Software systems used to evaluate pharyngeal pressure (WiscMano and Swallow gateway).
Measured: Baseline and 8 weeks
pHRM Pressure Change (Mesopharyngeal)
Will assess the change in pressure by pharyngeal high resolution manometry over the time frame. The primary measure of interest is Integral Pressure during the 10 mL swallow at the tongue base. This is measured in two forms:
- Pharyngeal Contractile Integral (PhCI): range is between 100 and 600 mmHg·s·cm ; 2. Mesopharyngeal Max Pressure (tongue base): range is between ~115-210 mmHg in healthy adults. Positive change would be a movement toward normal range of pressure. This metric is measured automatically in both Software systems used to evaluate pharyngeal pressure (WiscMano and Swallow gateway).
Measured: Baseline and 8 weeks
Swallowing Clinical and Fluoroscopic Change (MBSImP)
Will assess the change in fluoroscopy and clinical assessments over the time frame. The primary tool of measurement is the combined score of the Modified Barium Swallow Impairment Profile (MBSImP). This is a 17 item standardized tool to measure impairment of swallow identified using contrast barium swallows. The investigators will use the composite pharyngeal score which ranges from 0 to 3, the higher the score the more abnormal the swallow function, Normal swallows will score 5 or less and severe dysphagia will score 9 or higher. Movement toward 0 is a positive or improved swallow function, movement toward 23 is negative or worsening swallow function and full range is from 0 to 29 with a higher score indicating worse impairment. Scores under 13 indicate the mild or no impairment.
Measured: Baseline and 8 weeks
Patient Reported Outcome Changes (SSQ)
The Sydney Swallowing Questionnaire (SSQ) is a patient reported symptom scale with 17 questions, each scaled from 0+ no dysfunction to 100 equal extreme dysfunction using a 100mm visual analogue scale with 0 and 100 as anchors. The total score can be recorded for 0 to 1700. Normal swallowers will average 40 with a range of 200 to 0. Dysphagia patients average 800 with a range of 150 to 1600. Movement toward 0 will be considered an improvement, movement toward 1700 worsening in swallowing ability preserved by the patient.
Measured: Baseline and 8 weeks
Secondary outcomes (2)
Patient Reported Outcome Changes (EAT-10)
The Eating Assessment Tool-10 (EAT-10) is a short 10 question swallowing assessment tool with 10 questions each scaled 0 to 4, total can be between 0 and 40. The normal swallowers will score under 2. Changes toward 0 will be identified as improved swallow symptom function, changes toward 40 worsening symptoms.
Measured: Baseline and 8 weeks
Patient Reported Outcome Changes, Diet Change
International Dysphagia Diet Standardization initiative, Functional Oral Intake scale. Standardize scale of diet (liquid and solid food, iddsi.org). Foods scaled from regular diet 7 to liquidized 3, and liquids scaled from thin liquids 0 to extremely thick 4. Improvement in diet will be report if patients move toward 0 in liquid intake and toward 7 in solid food intact, and movement in the opposite directions will be evidence of poorly food and liquid tolerance.
Measured: Baseline, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start28 Jun 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be stratified into the following groups: Group A) Patient Group receiving Pharyngeal strengthening (n=150); and Group B) Healthy Controls (n=50). Participants' age may range from 18-99 years old, however, the investigators expect most study participants will be \>60 years old due to the age range typically affected by dysphagia.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Timothy M. McCulloch, MD, Principal investigator, William S. Middleton Memorial Veterans Hospital, Madison, WI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569097
- Sponsor's protocol ID
- N3221-R
- Status last verified
- Apr 2026
- First submitted
- 23 Sep 2020
- Last updated
- 11 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry
- ClinicalTrials.gov ID
- NCT04569097
- Acronym / sponsor ID
- N3221-R
- Conditions
- Dysphagia, Swallowing Disorders
- Keywords
- dysphagia, manometry, swallowing, veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Posted 11 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-site trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. A non-dysphagic Veteran control group will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to non-dysphagic controls using manometry, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.
The investigators aim to 1) quantify change in pressure measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pressure-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.
Detailed description
This multi-center trial will follow a cohort of Veterans with dysphagia for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 6-4 weeks post-treatment, and 8 weeks post-treatment. A non-dysphagic Veteran control group (n=50) will also undergo data collection at parallel time points, without completion of a treatment paradigm. The investigators will then compare patients to nondysphagic controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient reported outcome measures. The investigators aim to 1) quantify change in pHRM measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pHRM-based metrics best track with patient-reported outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be stratified into the following groups: Group A) Patient Group receiving Pharyngeal strengthening (n=150); and Group B) Healthy Controls (n=50). Participants' age may range from 18-99 years old, however, the investigators expect most study participants will be >60 years old due to the age range typically affected by dysphagia.
| Arm | Type | Receives |
|---|---|---|
| Patient group | Experimental | Other: standard of care lingual strengtheninglingual strengthening |
| Controls | No intervention | –No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed an informed consent form
- Receive a dysphagia diagnosis by a speech-language pathologist
- Must have a dysphagia treatment plan with the goal of strengthening the oropharyngeal musculature
- English speaking
Key exclusion criteria (2 listed)
- history of allergic response to barium
- history of allergic response to topical anesthetics
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 |
|---|---|---|
| standard of care lingual strengtheningstandard or care lingual strengthening approaches with outcome measured with novel pressure metrics | Other | Patient group |
Primary outcome
pHRM Pressure Change (Pharyngeal)
Time frame: Baseline and 8 weeks
Will assess the change in pressure by pharyngeal high resolution manometry over the time frame. The primary measure of interest is Integral Pressure during the 10 mL swallow at the tongue base. This is measured in two forms: 1. Pharyngeal Contractile Integral (PhCI): range is between 100 and 600 mmHg·s·cm ; 2. Mesopharyngeal Max Pressure (tongue base): range is between ~115-210 mmHg in healthy adults. Positive change would be a movement toward normal range of pressure. This metric is measured automatically in both Software systems used to evaluate pharyngeal pressure (WiscMano and Swallow gateway).
pHRM Pressure Change (Mesopharyngeal)
Time frame: Baseline and 8 weeks
Will assess the change in pressure by pharyngeal high resolution manometry over the time frame. The primary measure of interest is Integral Pressure during the 10 mL swallow at the tongue base. This is measured in two forms: 1. Pharyngeal Contractile Integral (PhCI): range is between 100 and 600 mmHg·s·cm ; 2. Mesopharyngeal Max Pressure (tongue base): range is between ~115-210 mmHg in healthy adults. Positive change would be a movement toward normal range of pressure. This metric is measured automatically in both Software systems used to evaluate pharyngeal pressure (WiscMano and Swallow gateway).
Swallowing Clinical and Fluoroscopic Change (MBSImP)
Time frame: Baseline and 8 weeks
Will assess the change in fluoroscopy and clinical assessments over the time frame. The primary tool of measurement is the combined score of the Modified Barium Swallow Impairment Profile (MBSImP). This is a 17 item standardized tool to measure impairment of swallow identified using contrast barium swallows. The investigators will use the composite pharyngeal score which ranges from 0 to 3, the higher the score the more abnormal the swallow function, Normal swallows will score 5 or less and severe dysphagia will score 9 or higher. Movement toward 0 is a positive or improved swallow function, movement toward 23 is negative or worsening swallow function and full range is from 0 to 29 with a higher score indicating worse impairment. Scores under 13 indicate the mild or no impairment.
Patient Reported Outcome Changes (SSQ)
Time frame: Baseline and 8 weeks
The Sydney Swallowing Questionnaire (SSQ) is a patient reported symptom scale with 17 questions, each scaled from 0+ no dysfunction to 100 equal extreme dysfunction using a 100mm visual analogue scale with 0 and 100 as anchors. The total score can be recorded for 0 to 1700. Normal swallowers will average 40 with a range of 200 to 0. Dysphagia patients average 800 with a range of 150 to 1600. Movement toward 0 will be considered an improvement, movement toward 1700 worsening in swallowing ability preserved by the patient.
2 secondary outcomes
Patient Reported Outcome Changes (EAT-10)
Time frame: Baseline and 8 weeks
Patient Reported Outcome Changes, Diet Change
Time frame: Baseline, 4 weeks, and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Timothy M. McCulloch, MD principal investigator
William S. Middleton Memorial Veterans Hospital, Madison, WI
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dysphagia and Swallowing Disorders, run by VA Office of Research and Development at 3 sites 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 4 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 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 11 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
pHRM Pressure Change (Pharyngeal) (time frame: Baseline and 8 weeks). The study lists 4 primary outcomes in all. 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 11 May 2026.