Back to resultsReduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia
Primary Purpose
Dysphagia, Stroke
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cereal extract concentration 1
Cereal extract concentration 2
Cereal extract concentration 3
Thicken up clear concentration 1
Thicken up clear concentration 2
Thicken up clear concentration 3
Sponsored by
About this trial
This is an interventional supportive care trial for Dysphagia
Eligibility Criteria
Inclusion Criteria:
- Mild dysphagia as defined by a score between 3 and 5 on the Dysphagia Outcome and Severity Scale
- Patients aged between 18 and 85 years
- Ischemic/hemorrhagic cerebral cause (stroke)
- Able to understand French (oral and written)
- Cognitive capacity enough to understand study procedures
- Having health insurance (which in France is " social security")
- Having signed the consent form.
Exclusion Criteria:
- Any swallowing trouble not resulting from the current stroke
- History of inhalation pneumopathy, i.e. any pulmonary inflammation linked to the path of a solid or liquid food in the respiratory system
- Any physician diagnosed psychiatric illness
- Patient with a digestive fistula
- Any physician diagnosed food allergy
- Any known allergy to barium or any compound of the contrast product
- Confirmed or suspected perforated and occlusive syndrome
- Pregnant or lactating women
- Major respiratory disease needing oxygen (chronic respiratory insufficiency)
- Subject who cannot be expected to comply with the study procedures, including consuming the test products.
- Currently participating or having participated in another clinical trial during the month preceding the study
Sites / Locations
- Grand hopital de Charleroi
- Centre Hospitalier Charles Nicolle
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Thicken Up Clear concentration 1
Thicken Up Clear concentration 2
Thicken Up Clear concentration 3
Cereal extract concentration 1
Cereal extract concentration 2
Cereal extract concentration 3
Arm Description
Thicken Up Clear at concentration 1
Thicken Up Clear at concentration 2
Thicken Up Clear at concentration 3
Cereal extract at concentration 1
Cereal extract at concentration 2
Cereal extract at concentration 3
Outcomes
Primary Outcome Measures
Identification of any systematic effect of cohesiveness on the efficacy of swallowing in dysphagic patients according to Rosenbek's Penetration-Aspiration Score (PAS) using videofluoroscopy
The PAS score across each bolus (5 mL and 10 mL)
Secondary Outcome Measures
Swallowing safety- prevalence of penetration
The prevalence of penetration in the population according to Rosenbek's PAS (score of 2-5) assessed using videofluoroscopy
Swallowing safety- prevalence of aspiration
The prevalence of aspiration in the population according to Rosenbek's PAS (score of 6-8) assessed using videofluoroscopy
Swallowing function- Amount/volume of oral and pharyngeal residues
The amount/volume of oral and pharyngeal residues assessed using videofluoroscopy
Swallowing function- Prevalence of subjects with oral and pharyngeal residues
The prevalence of subjects of oral and pharyngeal residues assessed using videofluoroscopy
Swallowing function- Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)
Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)
Swallowing function- Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing)
Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing)
Swallowing function- Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter)
Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter)
Swallowing function- Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter)
Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter)
Swallowing function-Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing)
Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing)
Swallowing function- Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure)
Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure)
Subjective perception of ease of swallowing and oropharyngeal sensation.
This will be assessed from a questionnaire.
Full Information
NCT ID
NCT02522351
First Posted
July 13, 2015
Last Updated
October 4, 2017
Sponsor
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT02522351
Brief Title
Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia
Official Title
Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia Due to Ischemic/Hemorrhagic Cerebral Cause (Stroke)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Stroke
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thicken Up Clear concentration 1
Arm Type
Active Comparator
Arm Description
Thicken Up Clear at concentration 1
Arm Title
Thicken Up Clear concentration 2
Arm Type
Active Comparator
Arm Description
Thicken Up Clear at concentration 2
Arm Title
Thicken Up Clear concentration 3
Arm Type
Active Comparator
Arm Description
Thicken Up Clear at concentration 3
Arm Title
Cereal extract concentration 1
Arm Type
Experimental
Arm Description
Cereal extract at concentration 1
Arm Title
Cereal extract concentration 2
Arm Type
Experimental
Arm Description
Cereal extract at concentration 2
Arm Title
Cereal extract concentration 3
Arm Type
Experimental
Arm Description
Cereal extract at concentration 3
Intervention Type
Other
Intervention Name(s)
Cereal extract concentration 1
Intervention Description
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Intervention Type
Other
Intervention Name(s)
Cereal extract concentration 2
Intervention Description
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Intervention Type
Other
Intervention Name(s)
Cereal extract concentration 3
Intervention Description
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Intervention Type
Other
Intervention Name(s)
Thicken up clear concentration 1
Intervention Description
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Intervention Type
Other
Intervention Name(s)
Thicken up clear concentration 2
Intervention Description
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Intervention Type
Other
Intervention Name(s)
Thicken up clear concentration 3
Intervention Description
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Primary Outcome Measure Information:
Title
Identification of any systematic effect of cohesiveness on the efficacy of swallowing in dysphagic patients according to Rosenbek's Penetration-Aspiration Score (PAS) using videofluoroscopy
Description
The PAS score across each bolus (5 mL and 10 mL)
Time Frame
During the ingestion (videofluoroscopy), maximum during one hour.
Secondary Outcome Measure Information:
Title
Swallowing safety- prevalence of penetration
Description
The prevalence of penetration in the population according to Rosenbek's PAS (score of 2-5) assessed using videofluoroscopy
Time Frame
During the ingestion (videofluoroscopy), maximum during one hour.
Title
Swallowing safety- prevalence of aspiration
Description
The prevalence of aspiration in the population according to Rosenbek's PAS (score of 6-8) assessed using videofluoroscopy
Time Frame
During the ingestion (videofluoroscopy), maximum during one hour.
Title
Swallowing function- Amount/volume of oral and pharyngeal residues
Description
The amount/volume of oral and pharyngeal residues assessed using videofluoroscopy
Time Frame
During the ingestion (videofluoroscopy), maximum during one hour.
Title
Swallowing function- Prevalence of subjects with oral and pharyngeal residues
Description
The prevalence of subjects of oral and pharyngeal residues assessed using videofluoroscopy
Time Frame
During the ingestion (videofluoroscopy), maximum during one hour.
Title
Swallowing function- Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)
Description
Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)
Time Frame
During the ingestion (videofluoroscopy), maximum during one hour.
Title
Swallowing function- Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing)
Description
Swallow response time (SRT, time between arrival of the bolus at the ramus of the mandible and pharyngeal phases of swallowing)
Time Frame
During the ingestion (videofluoroscopy), maximum during one hour.
Title
Swallowing function- Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter)
Description
Pharyngeal transit time (PTT, time between arrival of the bolus at the ramus of the mandible and the tail of the bolus passing through the upper esophageal sphincter)
Time Frame
During the ingestion (videofluoroscopy), maximum during one hour.
Title
Swallowing function- Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter)
Description
Time to upper esophageal sphincter opening (UESO, time between tongue tip elevation and opening of the upper esophageal sphincter)
Time Frame
During the ingestion (videofluoroscopy), maximum during one hour.
Title
Swallowing function-Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing)
Description
Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing)
Time Frame
During the ingestion (videofluoroscopy), maximum during one hour.
Title
Swallowing function- Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure)
Description
Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure)
Time Frame
During the ingestion (videofluoroscopy), maximum during one hour.
Title
Subjective perception of ease of swallowing and oropharyngeal sensation.
Description
This will be assessed from a questionnaire.
Time Frame
Right after ingredient ingestion, maximum during one hour.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild dysphagia as defined by a score between 3 and 5 on the Dysphagia Outcome and Severity Scale
Patients aged between 18 and 85 years
Ischemic/hemorrhagic cerebral cause (stroke)
Able to understand French (oral and written)
Cognitive capacity enough to understand study procedures
Having health insurance (which in France is " social security")
Having signed the consent form.
Exclusion Criteria:
Any swallowing trouble not resulting from the current stroke
History of inhalation pneumopathy, i.e. any pulmonary inflammation linked to the path of a solid or liquid food in the respiratory system
Any physician diagnosed psychiatric illness
Patient with a digestive fistula
Any physician diagnosed food allergy
Any known allergy to barium or any compound of the contrast product
Confirmed or suspected perforated and occlusive syndrome
Pregnant or lactating women
Major respiratory disease needing oxygen (chronic respiratory insufficiency)
Subject who cannot be expected to comply with the study procedures, including consuming the test products.
Currently participating or having participated in another clinical trial during the month preceding the study
Facility Information:
Facility Name
Grand hopital de Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Centre Hospitalier Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia
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