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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thicken Up Clear concentration 1 | Active Comparator | Thicken Up Clear at concentration 1 |
|
| Thicken Up Clear concentration 2 | Active Comparator | Thicken Up Clear at concentration 2 |
|
| Thicken Up Clear concentration 3 | Active Comparator | Thicken Up Clear at concentration 3 |
|
| Cereal extract concentration 1 | Experimental | Cereal extract at concentration 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cereal extract concentration 1 | Other | Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Swallowing safety- prevalence of penetration | The prevalence of penetration in the population according to Rosenbek's PAS (score of 2-5) assessed using videofluoroscopy | During the ingestion (videofluoroscopy), maximum during one hour. |
| Swallowing safety- prevalence of aspiration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grand hopital de Charleroi | Charleroi | 6000 | Belgium | |||
| Centre Hospitalier Charles Nicolle |
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| Cereal extract concentration 2 | Experimental | Cereal extract at concentration 2 |
|
| Cereal extract concentration 3 | Experimental | Cereal extract at concentration 3 |
|
| Cereal extract concentration 2 | Other | Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem |
|
| Cereal extract concentration 3 | Other | Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem |
|
| Thicken up clear concentration 1 | 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 | 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 | Other | Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem |
|
The prevalence of aspiration in the population according to Rosenbek's PAS (score of 6-8) assessed using videofluoroscopy |
| 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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) | During the ingestion (videofluoroscopy), maximum during one hour. |
| Subjective perception of ease of swallowing and oropharyngeal sensation. | This will be assessed from a questionnaire. | Right after ingredient ingestion, maximum during one hour. |
| Rouen |
| 76031 |
| France |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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