NCT02522351

Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia

Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia Due to Ischemic/Hemorrhagic Cerebral Cause (Stroke)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.

Detailed description

This trial will be a double blind, randomized, crossover, controlled, and interventional trial. Each subject will test 6 study samples in a randomized order at 5 mL of volume first then at 10 mL (12 samples maximum). The trial will last a maximum of one hour (a single study visit). The total sample size is 47 enrolled subjects, 33 subjects completed. Patients will be females and males aged between 18 and 85 years with mild proven dysphagia.

Conditions

• Dysphagia
• Stroke

Interventions

Type	Name	Description
OTHER	Cereal extract concentration 1	Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
OTHER	Cereal extract concentration 2	Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
OTHER	Cereal extract concentration 3	Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
OTHER	Thicken up clear concentration 1	Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
OTHER	Thicken up clear concentration 2	Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
OTHER	Thicken up clear concentration 3	Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-06-01
• Completion: 2017-09-01
• First posted: 2015-08-13
• Last updated: 2017-10-05

Locations

2 sites across 2 countries: Belgium, France