Oral Neuromuscular Training in Stroke Patients With Dysphagia
StrokeDysphagiaThis study aims to explore if oral neuromuscular training is superior to orofacial sensory-vibration stimulation in patients with oropharyngeal dysphagia. Four weeks after stroke onset, patients with oropharyngeal dysphagia and pathological swallowing according to the timed water swallow test (TWST) will be randomized 1:1 into a 5-week oral neuromuscular training with an oral device in addition to orofacial sensory-vibration stimulation with an electrical toothbrush (intervention group) or orofacial sensory-vibration stimulation only (control group). The participants will be examined with a TWST, lip force test, and videofluoroscopy (VFS) of oropharyngeal swallowing before (baseline), after 5-weeks training (end-of-training) and at a 12-18 months follow-up. The primary endpoint is changes in TWST at the end-of-training compared with baseline, and at late follow-up based on intention-to-treat analyses. The secondary endpoints are the corresponding changes in lip force and aspiration frequency at VFS.
Behavioural Intervention for Dysphagia in Acute Stroke
DysphagiaSwallowing dysfunction after stroke is common, but there is no reliable evidence for how it should be managed other than perhaps by nasogastric tube. This study compared the effectiveness of standardised, low and high intensity behavioral intervention for dysphagia with that of "usual care".
Exercise for Swallowing Problems After Stroke
Cerebrovascular AccidentDeglutition DisordersThe purpose of this study is to determine whether stroke patients with swallowing problems will show greater swallowing improvement with intense oral exercise than subjects who perform either a low intensity oral exercise or a sham exercise.
Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small...
DysphagiaNon-Small Cell Lung Cancer1 moreThe purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy followed by consolidation chemotherapy for treatment of unresectable stage III Non-Small Cell Lung Cancer (NSCLC).
A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients
Deglutition DisordersOtorhinolaryngologic Diseases1 moreOropharyngeal dysphagia (OD) is a highly prevalent and growing condition in the older population. It affects approximately one in three community-dwelling elderly, almost half of the geriatric patients, and even more than half of elderly nursing home residents. The main complications of OD are respiratory infections such as aspiration pneumonia, malnutrition, and dehydration. It supposes substantial costs for the healthcare system, increases the risk for (re)admissions and length of stay, and has an important impact on the quality of life of people who suffer from it. The aim of this study is to develop a predictive model to identify non-hospitalized older patients at risk for oropharyngeal dysphagia, quantify that risk, and facilitate decision-making according to personal, clinical, and socio-emotional characteristics.
Describe to Better Understand, the Mealtime of People With Parkinson's Disease Dependent on Food...
Parkinson DiseaseDeglutition DisordersThe main objective is to describe strategies (verbal, non-verbal (gesture, intonation), and environmental), designed and used by the assisting/aided dyad to feed a dysphagic dependent person by articulating the safe and hedonic dimensions in the context of Parkinson's disease or atypical parkinsonian syndrome during a meal
Chewing and Swallowing Training Program in Coffin-Lowry Syndrome
Swallowing DisorderChewing ProblemThis study will report the chewing and swallowing disorders of a Coffin-Lowry Syndrome (CLS) patient, and effects of chewing and swallowing training on chewing and swallowing function.
Acceptance of Different Thickeners in Dysphagia
DysphagiaDysphagia1 moreRandomized, controlled, pilot study of nutritional intervention to evaluate the acceptance to different kinds of thickeners, with and without the addition of flavoring.
Silk Protein Microparticle-based Filler for Injection Augmentation
Vocal Cord Paralysis UnilateralDysphonia2 moreThis study will investigate the safety and efficacy of a silk protein microparticle-based filler for vocal fold injection augmentation to treat dysphonia/dysphagia secondary to vocal fold paralysis. Participants will receive one injection and follow-up for a planned period of 12 months.
Bioequivalence Study of Crushed Elbasvir/Grazoprevir Compared to the Whole Tablet
Hepatitis CDeglutition DisordersElbasvir/grazoprevir (Zepatier®) is a once-daily tablet for the treatment of chronic hepatitis C virus (HCV) GT1a, 1b or 4 infection containing the NS5A inhibitor elbasvir (ELB) 50 mg and the NS3/4A protease inhibitor grazoprevir (GZR) 100 mg. For patients with swallowing difficulties, administration of whole tablets can be problematic. In addition, HCV patients that are hospitalized (at intensive care units) due to severe illness (co-infections/ liver failure) might not be able to swallow medication. Therefore it is useful to know whether it is possible to administer ELB/GZR through a different route, like a feeding tube. In daily practice, information about the safety and efficacy of crushed tablets is lacking which might result in noncompliance, interruption or discontinuation of expensive HCV therapy. However, it is not recommended to interrupt treatment because there is no evidence about the efficacy of the therapy after discontinuation (and restarting). Currently, patients and healthcare professionals are crushing tablets without information about efficacy and safety. Depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets can lead to altered pharmacokinetics of drugs. It is important to know whether pharmacokinetic parameters are influenced by crushing of tablets; both a decrease and an increase in exposure may occur. A decrease of the plasma concentrations of ELB and/or GZR potentially reduces the therapeutic effect of the drugs. Higher doses or switching to other HCV-drugs might be needed. In contrast, in case a higher Cmax and/or AUC occurs there might be an increased risk of toxicity. As a result, crushing the drug is a contra-indication based on the available data. Therefore this study will be conducted to investigate whether a crushed ELB/GZR tablet is bioequivalent to ELB/GZR as a whole tablet.