Novel Pharyngeal Metrics to Predict Dysphagia Outcomes
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Dysphagia
- Swallowing Disorders
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention 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)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04569097
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Timothy M. McCulloch, MD William S. Middleton Memorial Veterans Hospital, Madison, WI
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