No registrations found.
ID
Source
Brief title
Health condition
Dysphagia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage 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)
Background summary
This 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.
Study objective
H0: 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
Study design
V0 (screening); V1 ( Testday), Follow-up call
Intervention
Duration 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.
Mirjam Slagter
PO Box 80141
Utrecht 3508 TC
The Netherlands
+31 30 2095000// +31 631904702
Mirjam.Slagter@Nutricia.com
Mirjam Slagter
PO Box 80141
Utrecht 3508 TC
The Netherlands
+31 30 2095000// +31 631904702
Mirjam.Slagter@Nutricia.com
Inclusion criteria
1. 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 criteria
1. 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5363 |
| NTR-old | NTR5628 |
| Other | : DYS.2.C/B (Nutricia Research) |