An interventional study of standard of care lingual strengthening in Dysphagia and Swallowing Disorders, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Diagnostic
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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Exclusion Criteria:
lingual strengthening
Other: standard of care lingual strengthening
No history of dysphagia (swallowing disorder) or minimal to mild dysphagia not requiring a strengthening program
standard or care lingual strengthening approaches with outcome measured with novel pressure metrics
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 8 weeks
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.
Time frame: 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.
Time frame: Baseline, 4 weeks, and 8 weeks
| Milestone | Patient Group | Controls |
|---|---|---|
| Started | 112 | 115 |
| Completed | 79 | 75 |
| Not completed | 33 | 40 |
| Withdrew: Withdrawal by subject | 33 | 40 |
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).
| mmHg·s·cm | Patient Group | Controls |
|---|---|---|
| Baseline Pharyngeal Contractile Integral | 381 ± 128 | 395 ± 127 |
| 8 weeks Pharyngeal Contractile Integral | 389 ± 140 | 402 ± 111 |
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).
| mmHg | Patient Group | Controls |
|---|---|---|
| Baseline Mesopharyngeal Max Pressure | 192 ± 73 | 185 ± 56 |
| 8 weeks Mesopharyngeal Max Pressure | 200 ± 70 | 191 ± 61 |
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.
| score on a scale | Patient Group | Controls |
|---|---|---|
| Baseline MBSImP | 10.7 ± 3.2 | 6.0 ± 2.4 |
| 8 weeks MBSImP | 9.2 ± 2.4 | 6.8 ± 2.2 |
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.
| score on a scale | Patient Group | Controls |
|---|---|---|
| Baseline SSQ | 512 ± 358 | 149 ± 198 |
| 8 weeks SSQ | 377 ± 309 | 164 ± 185 |
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.
| score on a scale | Patient Group | Controls |
|---|---|---|
| Baseline EAT-10 | 13.8 ± 8.9 | 3.8 ± 6.6 |
| 8 weeks EAT-10 | 9.0 ± 8.5 | 4.0 ± 5.9 |
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.
Results for this outcome have not been posted.
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patient Group | 0/112 (0%) | 0/112 (0%) | 0/112 (0%) |
| Controls | 0/115 (0%) | 0/115 (0%) | 0/115 (0%) |
| Age, Categorical(Participants) | Patient Group | Controls | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 29 | 61 | 90 |
| >=65 years | 83 | 54 | 137 |
| Sex: Female, Male(Participants) | Patient Group | Controls | Total |
|---|---|---|---|
| Female | 2 | 22 | 24 |
| Male | 110 | 93 | 203 |
| Ethnicity (NIH/OMB)(Participants) | Patient Group | Controls | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 108 | 113 | 221 |
| Unknown or Not Reported | 3 | 1 | 4 |
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