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

NCT ID: NCT02522351

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-09-30

Brief Summary

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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

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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

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Dysphagia Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Thicken Up Clear concentration 1

Thicken Up Clear at concentration 1

Group Type ACTIVE_COMPARATOR

Cereal extract concentration 1

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 2

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 3

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 2

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 3

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken Up Clear concentration 2

Thicken Up Clear at concentration 2

Group Type ACTIVE_COMPARATOR

Cereal extract concentration 1

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 2

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 3

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 1

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 3

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken Up Clear concentration 3

Thicken Up Clear at concentration 3

Group Type ACTIVE_COMPARATOR

Cereal extract concentration 1

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 2

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 3

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 1

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 2

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 1

Cereal extract at concentration 1

Group Type EXPERIMENTAL

Cereal extract concentration 2

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 3

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 1

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 2

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 3

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 2

Cereal extract at concentration 2

Group Type EXPERIMENTAL

Cereal extract concentration 1

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 3

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 1

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 2

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 3

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 3

Cereal extract at concentration 3

Group Type EXPERIMENTAL

Cereal extract concentration 1

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Cereal extract concentration 2

Intervention Type OTHER

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 1

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 2

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Thicken up clear concentration 3

Intervention Type OTHER

Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Interventions

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Cereal extract concentration 1

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Intervention Type OTHER

Cereal extract concentration 2

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Intervention Type OTHER

Cereal extract concentration 3

Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Mild dysphagia as defined by a score between 3 and 5 on the Dysphagia Outcome and Severity Scale
2. Patients aged between 18 and 85 years
3. Ischemic/hemorrhagic cerebral cause (stroke)
4. Able to understand French (oral and written)
5. Cognitive capacity enough to understand study procedures
6. Having health insurance (which in France is " social security")
7. Having signed the consent form.

Exclusion Criteria

1. Any swallowing trouble not resulting from the current stroke
2. History of inhalation pneumopathy, i.e. any pulmonary inflammation linked to the path of a solid or liquid food in the respiratory system
3. Any physician diagnosed psychiatric illness
4. Patient with a digestive fistula
5. Any physician diagnosed food allergy
6. Any known allergy to barium or any compound of the contrast product
7. Confirmed or suspected perforated and occlusive syndrome
8. Pregnant or lactating women
9. Major respiratory disease needing oxygen (chronic respiratory insufficiency)
10. Subject who cannot be expected to comply with the study procedures, including consuming the test products.
11. Currently participating or having participated in another clinical trial during the month preceding the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Grand hopital de Charleroi

Charleroi, , Belgium

Site Status

Centre Hospitalier Charles Nicolle

Rouen, , France

Site Status

Countries

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Belgium France

Other Identifiers

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13.21. NRC

Identifier Type: -

Identifier Source: org_study_id