Clinical Trial: Development of Novel, Biophysically Designed Fluids for Swallowing Disorders

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Development of Novel, Biophysically Designed Fluids for Swallowing Disorders

Brief Summary: People suffering from swallowing disorders (dysphagia) have a hard time swallowing liquids that are too thin (like water or coffee) or too thick, correctly. They can have health problems, such as chest infections and malnutrition because when they try to drink, some of the liquid "goes down the wrong pipe" and into the lungs. To help people with dysphagia, Swallow Solutions is developing thickened liquids that have added nutrition, taste good, and quench thirst, but are still easy and safe to swallow.

Detailed Summary:

A. Background Dysphagia, a devastating swallowing disorder affecting more than 18M adults and millions more children in the U.S. [1,2], is associated with increased mortality and morbidity, including malnutrition, dehydration, pulmonary complications, and reduced quality of life [3,4]. Dysphagia often causes thin liquids (e.g., water, coffee) to be aspirated or misdirected into the pulmonary—rather than to the digestive—system during swallowing, significantly increasing the risk of aspiration pneumonia [5,6]. Radiographic methods used in >80% of U.S. hospitals to diagnose dysphagia involve standardized fluids with specific rheological characteristics (e.g., apparent viscosity, flow properties) [7]. Thickened beverages are the most commonly recommended intervention after dysphagia diagnosis [8]. Perplexingly, currently available dietary beverages differ from the rheological characteristics of standardized diagnostic fluids, causing a critical disconnect between diagnosis and treatment [9]. A rheologic study of commercially available thickened beverages and diagnostic fluids found that some commercial nectar products, while approaching the target apparent viscosity (n ) for the diagnostic standard (Varibar® Nectar, n 30=300 cP), differed in other rheological parameters such as flow index (n), consistency (K), and yield stress. o commercial thin-honey consistency products matched the diagnostic standard for any of these rheological parameters. This disconnect frequently causes the bolus to flow toward the airway, increasing the risk of negative health sequelae.

Swallow Solutions, LLC will build on the successful completion of our Phase I project to continue to bridge the gap between clinical need and existing products. Based on insights from our Phase I results, investigators will develop a complete product line (tentatively branded as SwallowSAFE Thicken
Sponsor: Swallow Solutions

Current Primary Outcome: Penetration - Aspiration Scale [ Time Frame: immediately while swallowing ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Post-swallow Residue [ Time Frame: immediately while swallowing ]

Original Secondary Outcome: Same as current

Information By: Swallow Solutions

Dates:
Date Received: April 24, 2017
Date Started: February 22, 2017
Date Completion: July 1, 2018
Last Updated: April 26, 2017
Last Verified: April 2017