Clinical trial NCT04569097: Novel Pharyngeal Metrics to Predict Dysphagia Outcomes
Official title: Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dysphagia
Swallowing Disorders
Keywords: dysphagia
manometry
swallowing
veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-09-29
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* history of allergic response to barium
* history of allergic response to topical anesthetics

Primary outcomes:
measure: pHRM pressure change
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Swallowing clinical and fluoroscopic change
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Patient reported outcome changes
timeFrame: Baseline, 4 weeks, and 8 weeks
Secondary outcomes:
measure: Patient reported outcome changes
timeFrame: Baseline, 4 weeks, and 8 weeks
measure: Patient reported outcome changes, Diet change
timeFrame: Baseline, 4 weeks, and 8 weeks
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center, Cincinnati, OH
state: Ohio
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
state: Wisconsin
Study officials:
affiliation: William S. Middleton Memorial Veterans Hospital, Madison, WI
name: Timothy M. McCulloch, MD
role: PRINCIPAL_INVESTIGATOR
References: