Clinical trial NCT04130867: Rehabilitation Manometry Study
Official title: Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oropharyngeal Dysphagia
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 300 adults will be recruited to participate in the study. Participants will include 250 patients with heterogeneous causes of dysphagia undergoing active swallowing treatment and 50 age- and sex-match control participants with healthy swallow function. Participants will be stratified into the following goals of swallowing rehabilitation: Group A) Pharyngeal strengthening (n=125); and Group B) Relief of upper esophageal sphincter (UES) dysfunction or pharyngeal outlet obstruction (n=125). Classification will be based on clinician-driven diagnoses and treatment goals based on standard of care evaluation. The control group of healthy individuals will be Group C (n=50).

Participants' age may range from 18-99 years old; as dysphagia is more frequent in the elderly, the sample will most likely include individuals age 60 and over.

Brief summary: Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects physiological and psychosocial functioning in 1 in 25 adults. Many dysphagia treatments exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal high-resolution manometry (pHRM) directly measures swallowing pressures, providing an objective measurement of physiology that characterizes the basic mechanisms of swallowing. pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective, and reproducible measures of swallowing function.

This proposed project will address a central hypotheses that objective swallowing measures (including (pHRM) will reveal treatment-mediated swallowing changes, will align with patient-reported outcome measures, and will be able to predict who will benefit from treatment. The investigators will follow a cohort of participants with oropharyngeal dysphagia as they undergo either pharyngeal strengthening therapy or relief of upper esophageal sphincter outlet obstruction at three time points: baseline, mid-treatment (4-6 weeks) and post-treatment (10-12 weeks). The investigators will compare participants to healthy controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.


Eligibility criteria: Inclusion Criteria:

* Pathological Group

  * Must have dysphagia as diagnosed by a licensed and certified otolaryngologist, gastroenterologist, or speech-language pathologist AND must have a dysphagia treatment plan that includes one of the following primary goals:

    * Therapy to strengthen oropharyngeal musculature
    * Medical or surgical management to relieve an obstruction at the upper esophageal sphincter
  * Must agree to comply with swallowing assessment, including interview and manometry
  * Must sign the Informed Consent form approved by the Health Sciences Institutional Review Board of the University of Wisconsin
* Normal Group

  * Having no swallowing disorders
  * Must agree to comply with swallowing assessment, including interview and manometry
  * Must sign the Informed Consent form approved by the Health Sciences Institutional Review Board of the University of Wisconsin.\\

Exclusion Criteria:

* Pathological Group

  * Therapeutic management plan already initiated prior to recruitment
  * Therapy goals including only improvement of swallowing coordination
  * Developmental disability, dementia, cognitive dysfunction, or difficulty comprehending instructions
  * Positive history of allergic response to topical anesthetic
  * Allergy to food relevant to study participation (e.g. lactose intolerance)
* Normal Group

  * Known swallowing disorder
  * Developmental disability, dementia, cognitive dysfunction, or difficulty comprehending instructions
  * Positive history of allergic response to topical anesthetic
  * Allergy to food relevant to study participation (e.g. lactose intolerance)

Primary outcomes:
measure: Change in pHRM from Baseline
timeFrame: up to 3 months
measure: Change in Sydney Swallowing Questionnaire between timepoints
timeFrame: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
measure: Change in Eat Assessment Tool Score between timepoints
timeFrame: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
measure: Change in Hand Grip Strength Test between timepoints
timeFrame: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
measure: Change in Maximum Isometric Pressure between timepoints
timeFrame: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
measure: Change in Dietary Assessment between timepoints
timeFrame: baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Timothy McCulloch, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: