Development of Novel, Biophysically Designed Fluids for Swallowing Disorders

NCT03131869 | Unknown

• 1 other identifier: 2R44NR015193-02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Deglutition Disorders

Outcome Measures

Primary Outcomes (1)

• Penetration - Aspiration Scale

  presence of aspiration/penetration of the laryngeal vestibule

  immediately while swallowing

Secondary Outcomes (1)

• Post-swallow Residue

  immediately while swallowing

Interventions

Thickened Beverages Nectar OTHER

Thickened beverages in nectar consistency

Thickened Beverage Honey OTHER

Thickened beverages in honey consistency

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Swallow Solutions: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Meriter Hospital

Madison, Wisconsin, 53715, United States

RECRUITING

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Eric Horler, MBA

  Swallow Solutions

  PRINCIPAL INVESTIGATOR

• JoAnne Robbins, PhD

  Swallow Solutions

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie Hind, MS

CONTACT

608-238-6678; jahind@swallowsolutions.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: February 22, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)