Reduction of Aspiration Through Cohesive Thin Liquids (CTL) in Patients With Mild Oropharyngeal Dysphagia
1 other identifier
interventional
35
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 13, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedOctober 5, 2017
October 1, 2017
2 years
July 13, 2015
October 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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)
During the ingestion (videofluoroscopy), maximum during one hour.
Secondary Outcomes (11)
Swallowing safety- prevalence of penetration
During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing safety- prevalence of aspiration
During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Amount/volume of oral and pharyngeal residues
During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Prevalence of subjects with oral and pharyngeal residues
During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)
During the ingestion (videofluoroscopy), maximum during one hour.
- +6 more secondary outcomes
Study Arms (6)
Thicken Up Clear concentration 1
ACTIVE COMPARATORThicken Up Clear at concentration 1
Thicken Up Clear concentration 2
ACTIVE COMPARATORThicken Up Clear at concentration 2
Thicken Up Clear concentration 3
ACTIVE COMPARATORThicken Up Clear at concentration 3
Cereal extract concentration 1
EXPERIMENTALCereal extract at concentration 1
Cereal extract concentration 2
EXPERIMENTALCereal extract at concentration 2
Cereal extract concentration 3
EXPERIMENTALCereal extract at concentration 3
Interventions
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Grand hopital de Charleroi
Charleroi, 6000, Belgium
Centre Hospitalier Charles Nicolle
Rouen, 76031, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2015
First Posted
August 13, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2017
Study Completion
September 1, 2017
Last Updated
October 5, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share