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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Cereal extract concentration 1 Other
    Intervention Desc: Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
    ARM 1: Kind: Experimental
    Label: Thicken Up Clear concentration 1
    Description: Thicken Up Clear at concentration 1
    ARM 2: Kind: Experimental
    Label: Thicken Up Clear concentration 2
    Description: Thicken Up Clear at concentration 2
    ARM 3: Kind: Experimental
    Label: Thicken Up Clear concentration 3
    Description: Thicken Up Clear at concentration 3
    ARM 4: Kind: Experimental
    Label: Cereal extract concentration 2
    Description: Cereal extract at concentration 2
    ARM 5: Kind: Experimental
    Label: Cereal extract concentration 3
    Description: Cereal extract at concentration 3
  • Cereal extract concentration 2 Other
    Intervention Desc: Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
    ARM 1: Kind: Experimental
    Label: Thicken Up Clear concentration 1
    Description: Thicken Up Clear at concentration 1
    ARM 2: Kind: Experimental
    Label: Thicken Up Clear concentration 2
    Description: Thicken Up Clear at concentration 2
    ARM 3: Kind: Experimental
    Label: Thicken Up Clear concentration 3
    Description: Thicken Up Clear at concentration 3
    ARM 4: Kind: Experimental
    Label: Cereal extract concentration 1
    Description: Cereal extract at concentration 1
    ARM 5: Kind: Experimental
    Label: Cereal extract concentration 3
    Description: Cereal extract at concentration 3
  • Cereal extract concentration 3 Other
    Intervention Desc: Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
    ARM 1: Kind: Experimental
    Label: Thicken Up Clear concentration 1
    Description: Thicken Up Clear at concentration 1
    ARM 2: Kind: Experimental
    Label: Thicken Up Clear concentration 2
    Description: Thicken Up Clear at concentration 2
    ARM 3: Kind: Experimental
    Label: Thicken Up Clear concentration 3
    Description: Thicken Up Clear at concentration 3
    ARM 4: Kind: Experimental
    Label: Cereal extract concentration 1
    Description: Cereal extract at concentration 1
    ARM 5: Kind: Experimental
    Label: Cereal extract concentration 2
    Description: Cereal extract at concentration 2
  • Thicken up clear concentration 1 Other
    Intervention Desc: Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
    ARM 1: Kind: Experimental
    Label: Thicken Up Clear concentration 2
    Description: Thicken Up Clear at concentration 2
    ARM 2: Kind: Experimental
    Label: Thicken Up Clear concentration 3
    Description: Thicken Up Clear at concentration 3
    ARM 3: Kind: Experimental
    Label: Cereal extract concentration 1
    Description: Cereal extract at concentration 1
    ARM 4: Kind: Experimental
    Label: Cereal extract concentration 2
    Description: Cereal extract at concentration 2
    ARM 5: Kind: Experimental
    Label: Cereal extract concentration 3
    Description: Cereal extract at concentration 3
  • Thicken up clear concentration 2 Other
    Intervention Desc: Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
    ARM 1: Kind: Experimental
    Label: Thicken Up Clear concentration 1
    Description: Thicken Up Clear at concentration 1
    ARM 2: Kind: Experimental
    Label: Thicken Up Clear concentration 3
    Description: Thicken Up Clear at concentration 3
    ARM 3: Kind: Experimental
    Label: Cereal extract concentration 1
    Description: Cereal extract at concentration 1
    ARM 4: Kind: Experimental
    Label: Cereal extract concentration 2
    Description: Cereal extract at concentration 2
    ARM 5: Kind: Experimental
    Label: Cereal extract concentration 3
    Description: Cereal extract at concentration 3
  • Thicken up clear concentration 3 Other
    Intervention Desc: Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
    ARM 1: Kind: Experimental
    Label: Thicken Up Clear concentration 1
    Description: Thicken Up Clear at concentration 1
    ARM 2: Kind: Experimental
    Label: Thicken Up Clear concentration 2
    Description: Thicken Up Clear at concentration 2
    ARM 3: Kind: Experimental
    Label: Cereal extract concentration 1
    Description: Cereal extract at concentration 1
    ARM 4: Kind: Experimental
    Label: Cereal extract concentration 2
    Description: Cereal extract at concentration 2
    ARM 5: Kind: Experimental
    Label: Cereal extract concentration 3
    Description: Cereal extract at concentration 3

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Supportive Care
  • Endpoint: Safety/Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 During the ingestion (videofluoroscopy), maximum during one hour. Yes
Secondary Swallowing safety- prevalence of penetration During the ingestion (videofluoroscopy), maximum during one hour. Yes
Secondary Swallowing safety- prevalence of aspiration During the ingestion (videofluoroscopy), maximum during one hour. Yes
Secondary Swallowing function- Amount/volume of oral and pharyngeal residues During the ingestion (videofluoroscopy), maximum during one hour. Yes
Secondary Swallowing function- Prevalence of subjects with oral and pharyngeal residues During the ingestion (videofluoroscopy), maximum during one hour. Yes
Secondary 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. Yes
Secondary Swallowing function- 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. Yes
Secondary 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) During the ingestion (videofluoroscopy), maximum during one hour. Yes
Secondary Swallowing function- 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. Yes
Secondary Swallowing function-Time to laryngeal vestibule opening (LVO, time between tongue tip elevation and pharyngeal phases of swallowing) During the ingestion (videofluoroscopy), maximum during one hour. Yes
Secondary Swallowing function- Time to laryngeal vestibule closure (LVC, time between tongue tip elevation and maximal laryngeal closure) During the ingestion (videofluoroscopy), maximum during one hour. Yes
Secondary Subjective perception of ease of swallowing and oropharyngeal sensation. Right after ingredient ingestion, maximum during one hour. No

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