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…
ID
Bron
Verkorte titel
Aandoening
Dysphagia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Percentage of subjects that swallow viscosity levels 1, 2 and 3 safely (PAS score 1,2) compared to thin iodine liquid control
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
V0 (screening); V1 ( Testday), Follow-up call
Onderzoeksproduct en/of interventie
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.
Publiek
Mirjam Slagter
PO Box 80141
Utrecht 3508 TC
The Netherlands
+31 30 2095000// +31 631904702
Mirjam.Slagter@Nutricia.com
Wetenschappelijk
Mirjam Slagter
PO Box 80141
Utrecht 3508 TC
The Netherlands
+31 30 2095000// +31 631904702
Mirjam.Slagter@Nutricia.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5363 |
| NTR-old | NTR5628 |
| Ander register | : DYS.2.C/B (Nutricia Research) |