Novel Pharyngeal Metrics to Predict Dysphagia Outcomes
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|ClinicalTrials.gov Identifier: NCT04569097|
Recruitment Status : Recruiting
First Posted : September 29, 2020
Last Update Posted : September 8, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Dysphagia Swallowing Disorders||Other: standard of care lingual strengthening||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Outcomes Assessor)|
|Official Title:||Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry|
|Actual Study Start Date :||June 28, 2021|
|Estimated Primary Completion Date :||March 29, 2024|
|Estimated Study Completion Date :||September 30, 2025|
Experimental: Patient group
Other: standard of care lingual strengthening
standard or care lingual strengthening approaches with outcome measured with novel pressure metrics
No Intervention: Healthy controls
Healthy normal swallow
- pHRM pressure change [ Time Frame: Baseline, 4 weeks, 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 Range is From: 0 mmHg*sec, no pressure recorded to up to 250 mmHg*sec., very high pressures recorded, normal range is age and sex dependent Range (114+/-50 to167 +/-80) 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 [ Time Frame: Baseline, 4 weeks, 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 MBSImP this is a 17 item standardized tool to measure impairment of swallow identified using contrast barium swallows. We 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
- Patient reported outcome changes [ Time Frame: Baseline, 4 weeks, and 8 weeks ]Sydney swallowing questionnaire (SSQ) The 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.
- Patient reported outcome changes [ Time Frame: Baseline, 4 weeks, and 8 weeks ]
Eating assessment tool -10, The Eat 10 is a short 10 question swallowing assessment tool 10 questions each scaled 0 to 4, total can be between 0 and 40.
The normal swallowers will score under 2. The mean (+/- SD) EAT-10 score of the normal cohort was 0.40 +/- 1.01.
The mean EAT-10 score for those with oropharyngeal dysphagia, 23.10 +/- 12.22 Changes toward 0 will be identified as improved swallow symptom function, changes toward 40 worsening symptoms
- Patient reported outcome changes, Diet change [ Time Frame: Baseline, 4 weeks, and 8 weeks ]International Dysphagia Diet Standardization initiative, Functional Oral intact 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 think 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569097
|Contact: Aaron F Heneghan, PhD||(608) 256-1901 ext 17801||Aaron.Heneghan@va.gov|
|Contact: Jenna W Quinto, PhD||(680) 256-1901 ext email@example.com|
|United States, Illinois|
|Edward Hines Jr. VA Hospital, Hines, IL||Not yet recruiting|
|Hines, Illinois, United States, 60141-5000|
|Contact: Laura Chalcraft, MS 708-202-4934 firstname.lastname@example.org|
|United States, Ohio|
|Cincinnati VA Medical Center, Cincinnati, OH||Not yet recruiting|
|Cincinnati, Ohio, United States, 45220|
|Contact: Kathy Welden, PhD 513-861-3100 ext 5226 email@example.com|
|United States, Wisconsin|
|William S. Middleton Memorial Veterans Hospital, Madison, WI||Recruiting|
|Madison, Wisconsin, United States, 53705|
|Contact: Aaron F Heneghan, PhD 608-256-1901 ext 17801 Aaron.Heneghan@va.gov|
|Contact: Jenna W Quinto, PhD (680) 256-1901 ext 17865 firstname.lastname@example.org|
|Principal Investigator: Timothy M. McCulloch, MD|
|Principal Investigator:||Timothy M. McCulloch, MD||William S. Middleton Memorial Veterans Hospital, Madison, WI|