The aim of the trial is to identify any systematic effect of cohesiveness on the efficacy of swallowing in patients having dysphagia problems.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
35
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
Grand hopital de Charleroi
Charleroi, Belgium
Centre Hospitalier Charles Nicolle
Rouen, France
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)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing safety- prevalence of penetration
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.
Swallowing safety- prevalence of aspiration
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.
Swallowing function- Amount/volume of oral and pharyngeal residues
The amount/volume of oral and pharyngeal residues assessed using videofluoroscopy
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Swallowing function- Prevalence of subjects with oral and pharyngeal residues
The prevalence of subjects of oral and pharyngeal residues assessed using videofluoroscopy
Time frame: 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)
Oral transit time (OTT, time between tongue tip elevation and arrival of the bolus at the ramus of the mandible)
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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
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
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)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
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)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
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)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
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)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
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)
Time frame: During the ingestion (videofluoroscopy), maximum during one hour.
Subjective perception of ease of swallowing and oropharyngeal sensation.
This will be assessed from a questionnaire.
Time frame: Right after ingredient ingestion, maximum during one hour.