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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient group | Experimental | lingual strengthening |
|
| Controls | No Intervention | No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard of care lingual strengthening | Other | standard or care lingual strengthening approaches with outcome measured with novel pressure metrics |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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: 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). | 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: 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). | 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. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy M. McCulloch, MD | William S. Middleton Memorial Veterans Hospital, Madison, WI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141-3030 | United States | ||
| Cincinnati VA Medical Center, Cincinnati, OH |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Group | lingual strengthening |
| FG001 | Controls | No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Group | lingual strengthening |
| BG001 | Controls | No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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: 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). | Posted | Mean | Standard Deviation | mmHg·s·cm | Baseline and 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Group | lingual strengthening | 0 |
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Earlier in the study we encountered more subject withdrawals due to manometry catheter placement discomfort. We have addressed the issue with the use of atomized lidocaine and oxymetazoline at two of our sites.
Delays in procurement of the saline.
COVID 19 pandemic affected recruitment.
Research Coordinators turn over.
Travel restrictions due to COVID 19 delayed manometry training in the other two sites.
A delay to establish new process to pay Dep of Radiology this led to delay in Controls
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzan Abdelhalim | VDORD or local VA medical center | 608-268-1901 | 11125 | Suzan.abdelhalim@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2025 | Jan 21, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 21, 2023 | Sep 23, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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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.
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| 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. | 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. | Baseline, 4 weeks, and 8 weeks |
| Cincinnati |
| Ohio |
| 45220-2213 |
| United States |
| William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin | 53705-2254 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program |
|
|
| Primary | 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: 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). | Posted | Mean | Standard Deviation | mmHg | Baseline and 8 weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 8 weeks |
|
|
|
| Secondary | 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. | Not Posted | Jun 2026 | Baseline, 4 weeks, and 8 weeks | Participants |
| 112 |
| 0 |
| 112 |
| 0 |
| 112 |
| EG001 | Controls | No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program | 0 | 115 | 0 | 115 | 0 | 115 |
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| D010038 | Otorhinolaryngologic Diseases |