Rehabilitation Manometry Study

Oropharyngeal Dysphagia Clinical Trial

Official title:

Defining Novel Pharyngeal Pressure Metrics to Predict Dysphagia Treatment Outcomes and Clinical Prognosis Using High-resolution Manometry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04130867
• Other study ID #: 2019-0576
• Secondary ID: A539770SMPH/SURG
• Status: Recruiting
• Start date: November 11, 2020
• Est. completion date: November 2024

Study information

• Verified date: June 2024
• Source: University of Wisconsin, Madison
• Contact: Suzan Abdelhalim, MD, MPH
• Phone: 608-265-2470
• Email: abdelhalim[@]surgery.wisc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Deglutition Disorders
• Oropharyngeal Dysphagia

Intervention

Procedure:
• pHRM
Pharyngeal high--resolution manometry (pHRM) provides direct and objective measurement of pressure changes in the pharynx that characterize basic mechanisms of swallowing.
• VFSS
Videofluoroscopic Swallow Study (VFSS) enables real-time visualization of bolus flow during swallow movement.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pHRM from Baseline	pHRM data collected from the 250 adults undergoing dysphagia treatment and 50 healthy controls at three time points (baseline, mid-treatment, and post-treatment) will be used.	up to 3 months
Primary	Change in Sydney Swallowing Questionnaire between timepoints	The Sydney Swallowing Questionnaire is a 17-item inventory scored on a visual analog scale (VAS) (with the exception of Q12) developed to measure symptomatic severity of pharyngeal dysphagia. Each VAS is 100 mm, where the left side of the scale is lesser symptoms and the right hand of the scale is increased symptoms. Scoring is measured in distance (mm) from the left. Maximum range in the scoring is 0 - 1700, the higher the score, the more severe the symptoms.	baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Primary	Change in Eat Assessment Tool Score between timepoints	The Eat Assessment Tool is a 10-item survey where each item is scored 0-4 where 0 is no problem and 4 is severe problem. The total range in score is 0-40 where higher scores indicate increased severity of symptoms.	baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Primary	Change in Hand Grip Strength Test between timepoints	Participants will squeeze a dynamometer at maximum pressure 3 times and hold for 5 seconds each. 10 seconds rest will be given between each trial.	baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Primary	Change in Maximum Isometric Pressure between timepoints	The Iowa Oral Pressure Instrument (IOPI) will be used to measure maximum isometric pressure. IOPI will be used to evaluate anterior and posterior maximal isometric tongue-pressures. A small (3.5 cm long and 4.5 cm in diameter) air-filled plastic pressure bulb will be placed in the mouth at two different positions: directly posterior to the incisors and at the posterior oral tongue. Participants will be asked to squeeze the bulb against the roof of the mouth with maximal effort and to perform saliva swallows. Three tasks in each position will be recorded and participants will rest for 10 seconds between each trial.	baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks
Primary	Change in Dietary Assessment between timepoints	Participants will undergo diet assessment by using International Dysphagia Diet Standardisation Initiative Framework. This framework defines and scores food textures/consistencies for participants with dysphagia. Liquids are scored 0-4 where 0 is thin and 4 is extremely thick. Foods are scored from 3-7 where 3 is liquidized food and 7 is regular food.	baseline, mid-treatment 4-6 weeks, post-treatment 10-12 weeks