Recruiting

Swallowing Disorders

Sponsor:

Swallow Solutions

Code:

NCT03131869

Conditions

Deglutition Disorders

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Thickened Beverages Nectar

Thickened Beverage Honey

Study Details

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

Study ID

NCT03131869

Start date

Feb 22, 2017

Status verified date

Apr, 2017

Completion date

Jul 1, 2018

Anticipated

Primary completion date

Jul 1, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Interventions

Thickened Beverages Nectar

Thickened beverages in nectar consistency

Thickened Beverage Honey

Thickened beverages in honey consistency

Primary outcome measure

  • Penetration - Aspiration Scale [ Time Frame: immediately while swallowing ]

Central Contacts and Locations

Central contacts

Jackie Hind, MS

608-238-6678jahind@swallowsolutions.com

Locations

Meriter Hospital

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Sharon Bair, MS

608-417-6000sharon.bair@unitypoint.org

Marshfield Clinic

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Lisa Bast, MS

715-387-5511bast.lisa@marshfieldclinic.org

More Information

Sponsor

Swallow Solutions

Last update posted

Apr 28, 2017

Last verified

Apr, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Swallow Solutions on 2017-04-28.