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Effect of gum-based bolus viscosities on the safety of swallowing in patients with chronic post-stroke oropharyngeal dysphagia


- candidate number23625
- NTR NumberNTR5628
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2016
- Secondary IDsDYS.2.C/B (Nutricia Research) 
- Public TitleEffect of gum-based bolus viscosities on the safety of swallowing in patients with chronic post-stroke oropharyngeal dysphagia
- Scientific TitleEffect of gum-based bolus viscosities on the safety of swallowing in patients with chronic post-stroke oropharyngeal dysphagia
- ACRONYMTripleS
- hypothesisH0: The effect of at least one of the gum-thickened viscosities is equal to the effect using thin liquid, with respect to the safety of swallowing in patients with chronic post stroke oropharyngeal dysphagia.
H1: The effect of using gum-thickened viscosity level 3 is unequal to the effect of using thin liquid and the effect of using gum-thickened viscosity level 2 is unequal to the effect of using thin liquid and the effect of using gum-thickened viscosity of levels 1 is unequal to the effect of using thin liquid with respect to the safety of swallowing in patients with chronic post stroke oropharyngeal dysphagia
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. Diagnosis of stroke, and minimum 28 days since stroke
2. Clinical signs or symptoms of swallowing dysfunction, based on Eating Assessment Tool (EAT-10) questionnaire, or bedside clinical test or water swallow test, or referral by medical doctor for Video FluoroScopy (VFS)-test, or current use of thickened products
3. No alterations in consciousness (score of 0 or 1 in the first question of NIH Stroke Scale (NIHSS))
4. Age ≥ 18y
5. Written informed consent
- Exclusion criteria1. Patients with respiratory insufficiency in need of additional oxygen
2. Dysphagia not related to stroke
3. History of progressive neurological disorders (e.g. Parkinson’s disease, MS)
4. Tumour or radiotherapy of the head and neck region
5. Unstable medical conditions that may interfere with VFS
6. Patients with swallowing dysfunction caused by xerostomia induced by drugs
7. Prior medical history or conditions (like tracheostomy tube) that would put the patient at risk of pre-existing swallow disorder
8. Severe cognitive disorders or Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements and instructions
9. Not able to undergo VFS due to incapability of sitting posture
10. Known pregnancy and/or lactating
11. Participation in any other studies involving investigational or marketed products within four weeks prior to start of the study
12. Allergy to any ingredient of test product or iodine products
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 1-feb-2016
- planned closingdate31-dec-2017
- Target number of participants120
- InterventionsDuration of intervention: 1-10 days Intervention: thin iodine liquid as control versus iodine liquid thickened with a gum based thickener to different viscosity levels. Each variety will be given as a bolus in duplicate.
- Primary outcomePercentage of subjects that swallow viscosity levels 1, 2 and 3 safely (PAS score 1,2) compared to thin iodine liquid control
- Secondary outcome• Safety of swallowing per individual viscosity as measured by:
• Percentage of subjects that swallow safely (PAS score 1,2)
• Percentage of subjects with penetration (PAS score 3,4,5)
• Percentage of subjects with aspiration (PAS score 6,7,8)
• Mean PAS score
• Efficacy of swallowing per individual viscosity as expressed by:
• Presence and severity of oral residue (score 0,1,2) Presence and severity of pharyngeal residue (score 0,1,2)
- TimepointsV0 (screening); V1 ( Testday), Follow-up call
- Trial web siten/a
- statusplanned
- CONTACT FOR PUBLIC QUERIES Mirjam Slagter
- CONTACT for SCIENTIFIC QUERIES Mirian Lansink
- Sponsor/Initiator Nutricia Research BV
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research Foundation
- Publicationsn/a
- Brief summaryThis reference controlled, multiple dose, fixed order, single-blind and single-centre study is designed to evaluate whether addition of a gum based thickener increases safe swallowing compared to thin liquid in patients with chronic post-stroke oropharyngeal dysphagia.
- Main changes (audit trail)
- RECORD21-jan-2016 - 27-feb-2016


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