Clinical trial NCT03131869: Development of Novel, Biophysically Designed Fluids for Swallowing Disorders
Official title: Development of Novel, Biophysically Designed Fluids for Swallowing Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Deglutition Disorders
Lead sponsor: Swallow Solutions
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-04-27
Enrollment: 200
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Potential subjects will be adults with suspected dysphagia based on referral for a diagnostic videofluoroscopic swallowing evaluation. Only subjects who can consent for themselves will be enrolled in the study. The consent will take place before the swallow study begins. The study will include patients with a variety of medical etiologies to allow for greater generalizability of results. Pregnant women will be excluded from this protocol. Per standard clinical care (as all subjects will be completing the radiologic procedure regardless of participation in the study), pregnancy test will not be required.

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 description: 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 Thickened Beverages) to meet the unique-currently unmet-needs of dysphagic patients. This novel thickened beverage line will provide hydration and nutrition, thus circumventing potentially life-threatening and costly health problems associated with dysphagia. The investigators propose to accomplish the following specific aims.

Specific Aims

Aim 1. Complete a full complement of prototype ready-to-drink, thickened, and nutritionally-enhanced medical liquids that are shelf-stable and appealing, with pre-determined rheological and nutritional properties. T

Aim 2. Demonstrate improved patient safety resulting from novel, biophysically designed thickened beverages (full product line) compared to currently available thickened beverage options.

Aim 3. Develop production for the full SwallowSAFE product line of ready-to-drink, thickened beverages (with and without nutritional enrichment) at 2 target viscosities (nectar and thin-honey) in 1-3 flavors each.

B. Study Design: Clinical Research (Aim 2)

Dysphagic patients (n=200) will swallow prototype beverages (with 10% added barium) and also thickened beverages that are currently on the market (with 10% added barium) during a videofluoroscopic (radiographic) evaluation of swallowing that is part of their standard clinical care. The investigators will use established, quantified, objective safety measures of a) airway invasion (Penetration/Aspiration Scale) \[13,14\] and b) oropharyngeal residue \[15\]. Potential subjects will be adults (age \>55 years) with suspected dysphagia based on referral for the diagnostic evaluation. The study will include patients with a variety of medical etiologies to allow for greater generalizability of results. Each consenting subject will complete a videofluoroscopic swallowing assessment lasting \~45 min per standard clinical care. Data will be collected from 200 subjects from two large acute-care hospitals.

Eligibility criteria: Inclusion Criteria:

* 55 years of age or older
* physician approval of medical stability
* aspiration or penetration of the laryngeal vestibule (score of 3 or higher on the Penetration/Aspiration Scale) or post-swallow residue in the oropharynx as instrumentally documented by a Speech-Language Pathologist (SLP) during a standard videofluoroscopic oropharyngeal swallow study
* capacity to provide informed consent.

Exclusion Criteria:

* poorly controlled psychosis (3 or more related hospitalizations in one year
* refractory alcoholism (on AWD precautions)
* allergy to barium (used in radiographic swallowing assessment)

Primary outcomes:
measure: Penetration - Aspiration Scale
timeFrame: immediately while swallowing
Secondary outcomes:
measure: Post-swallow Residue
timeFrame: immediately while swallowing
Other outcomes:
Locations:
city: Madison
country: United States
facility: Meriter Hospital
state: Wisconsin
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
Study officials:
affiliation: Swallow Solutions
name: Eric Horler, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Swallow Solutions
name: JoAnne Robbins, PhD
role: PRINCIPAL_INVESTIGATOR
References: