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Oropharyngeal Dysphagia clinical trials

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NCT ID: NCT05278039 Recruiting - Clinical trials for Head and Neck Cancer

Training Swallowing Initiation During Expiration

Start date: August 12, 2021
Phase: N/A
Study type: Interventional

Head and neck cancers have escalated to epidemic levels in the United States, and survivors are suffering from life-long, devastating swallowing disorders with limited therapeutic options. This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to improve swallowing safety and efficiency.

NCT ID: NCT04741620 Completed - Dysphagia Clinical Trials

Subacute Effect of Pharyngeal Pharmacological Sensory Stimulation in Elderly Patients With Oropharyngeal Dysphagia

FIS2018
Start date: January 17, 2019
Phase: N/A
Study type: Interventional

Oropharyngeal sensory impairments are a potential target for treatment of oropharyngeal dysphagia (OD) in older patients. We previously found acute administration of TRP sensory stimulants improved VFS signs and swallow response. We hypothesized that sub-acute administration of TRP pharyngeal sensory stimulants, would improve cortical neuroplasticity and will lead into a faster and stronger swallow response, however desensitization of TRP receptors may occur. Therefore, the aim of the present study was to assess the biomechanical (Videofluoroscopy) and neurophysiological (pharyngeal sensory evoked potentials -PSEPs- and motor-evoked potentials (MEPs)) effect of 2 week treatment with TRP agonists in older patients with OD. Design: 150 older (>70yr) patients with OD will be included in a Randomized Control Trial assessing the effect of oral administration of either: a) capsaicin (TRPV1); b) piperine (TRPV1/TRPA1) c) cinnamaldehyde (TRPA1); d) citric acid (ASIC3); e) capsaicin+citric acid (TRPV1/ASIC3); and f) placebo (Control). Measurements: 1) VFS signs of safety and efficacy of swallow and timing and extent of swallow response; 2) Latency, amplitude and cortical representation of PSEP and MEP; 3) Substance P concentration in saliva by ELISA as a marker of peripheral stimulation. Results from this study might help to develop new and effective pharmacological treatments for older dysphagic patients, from compensation to recovery of swallow function.

NCT ID: NCT04695600 Recruiting - Clinical trials for Oropharyngeal Dysphagia

Onabotulinum Toxin A (Botox) in the Treatment of Transfer Dysphagia

Start date: August 22, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Dysphagia in patients with stroke, multiple sclerosis, parkinsonism or dystonia can occur due to relative hypertonia of the cricopharyngeus muscle. In the resting state, muscle is contracted and relaxes only during deglutition. Treatment of dysphagia by injecting botulinum toxin in the cricopharyngeus was described by Schneider et al. in 1994. More than 100 cases have been described after that, however there are no randomized controlled trials. A meta-analysis from Cochrane has also concluded that there is no sufficient evidence to conclude regarding the efficacy and safety of Botulinum toxin injection in cricopharyngeal dysfunction. So this study is necessary to fill this void in knowledge

NCT ID: NCT04581486 Recruiting - Malnutrition Clinical Trials

Effectiveness of an Optimal-Massive Intervention in Older Patients With Dysphagia

OMI
Start date: June 6, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the efficacy of an optimal-massive intervention (OMI) based on increasing shear viscosity of fluids, nutritional support with oral nutritional supplements (ONS) and triple adaptation of food (rheological and textural, caloric and protein and organoleptic) and oral hygiene improvement on the incidence of respiratory infections in older patients with OD. We have designed a randomized clinical trial, with two parallel arms and 6 months follow-up. The study population will be constituted by older patients of 70 years or more with OD hospitalized at Hospital de Mataró by an acute process that will be identified by using the volume-viscosity swallow clinical test. We will consecutively recruit 500 subjects during admission (Geriatrics, Internal medicine, etc.) at the Hospital de Mataró. Patients included will be randomly assigned to one of both interventional groups: a) study intervention: multifactorial intervention based on fluid viscosity adaptation (with a xanthan gum thickener -> Nutilis Clear®), nutritional support with a triple adaptation of food (texture, caloric and protein content, organoleptic) + pre-thickened ONS and evaluation and treatment of oral hygiene (tooth brushing + antiseptic mouthwashes + professional dental cleaning), or b) control intervention: standard clinical practice (fluid adaptation with Nutilis Powder and simple texture adaptation for solids). Main outcome measures: respiratory infection incidence during the 6-month period follow-up. Secondary outcomes: mortality at 6 months, general hospital readmissions and readmissions due to respiratory infections, nutritional status, hydration status, quality of life, functional status, oral hygiene and dysphagia severity and its relationship with other study variables.

NCT ID: NCT04477460 Recruiting - Clinical trials for Oropharyngeal Dysphagia

Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event

BRUE
Start date: April 1, 2021
Phase:
Study type: Observational

This observational study will examine the effects of thickened feeds on clinical outcomes and healthcare utilization in infants with brief resolved unexplained event (BRUE).

NCT ID: NCT04359199 Recruiting - Clinical trials for Head and Neck Cancer

QUantitative Assessment of Swallowing After Radiation (QUASAR)

QUASAR
Start date: September 1, 2020
Phase:
Study type: Observational

To use novel methods for quantitative analysis of VFSS (videofluoroscopic swallow study, also known as modified barium swallow) to study and compare dysphagia in patients treated for head and neck carcinoma with concurrent radiation therapy and chemotherapy (cisplatin) or targeted therapy (cetuximab) vs. immunotherapy (pembrolizumab, nivolumab, or durvalumab). Our hypothesis is that pharyngeal constriction will be greater (lower ratio) with concurrent immunotherapy compared to chemotherapy, as measured by the pharyngeal constriction ratio (PCR).

NCT ID: NCT04346212 Completed - COVID-19 Clinical Trials

Oropharyngeal Dysphagia in Patients With COVID-19

Start date: April 14, 2020
Phase:
Study type: Observational

Background: Oropharyngeal dysphagia (OD) is a common complication in/post ICU patients that have been with intubation/mechanical ventilation or with tracheotomies or NG tubes, in patients with acute respiratory infection/pneumonia/respiratory insufficiency with a severe disease needing high concentration of oxygen or noninvasive mechanical ventilation and also in patients discharged from acute hospitals to rehabilitation centers, nursing homes or other facilities. All these situations are common for COVID-19 patients that are currently filling our hospitals due to the pandemic expansion of SARS-CoV-2. OD is associated to prolonged hospitalization, dehydration and severe nutritional and respiratory complications -aspiration pneumonia-, hospital readmissions and mortality. Aim: to assess the prevalence of OD and nutritional risk in these patients and to know their needs of compensatory treatment following the application of an early intervention, and to assess whether OD and malnutrition are indicators of poor prognosis for COVID-19 patients. Methods: prospective study in which we will use the volume-viscosity swallowing test (V-VST) to assess the prevalence of OD, and NRS2002 to assess the nutritional risk in admitted patients with confirmed COVID-19 at the Consorci Sanitari del Maresme, Catalonia, Spain. We will register also results of the EAT-10, nutritional status, the needs of compensatory treatments of these patients following an early intervention with fluid and nutritional adaptation and use of nutritional supplements. We will also collect other clinical variables from medical history of the patient related to hospitalization and we will follow the clinical complications and nutritional status at 3 and 6 months follow up.

NCT ID: NCT04132271 Enrolling by invitation - Clinical trials for Oropharyngeal Dysphagia

Swallowing and Nutritional Treatment on OD Patients

OD
Start date: December 3, 2019
Phase: N/A
Study type: Interventional

Dysphagia is a difficulty during the swallowing process (transportation food from the mouth to the stomach. Oropharyngeal Dysphagia (OD) is diagnosed by videofluoroscopy and faringolaringoscopy. OD threatens the efficacy and safety of swallowing, contributing to an increased risk of aspiration and pneumonia. There are different interventions aimed to change and improve the physiology of swallowing; however, OD can be an important predictor of the progression of malnutrition in different types of patients. Malnutrition is defined as an acute or chronic disease whereby an energy imbalance, lack of energy, protein or other nutrients causes measurable and adverse effects on body composition, functional and clinical outcomes. In addition, it leads to a decrease in the quality of life. Objective: To establish a strategy of nutritional treatment and swallowing rehabilitation in patients with dysphagia. Hypothesis: An adequate nutritional intervention in content and consistency, combined with swallowing rehabilitation in patients with dysphagia, will improve the nutritional status and clinical evolution of patients with dysphagia.

NCT ID: NCT04130867 Recruiting - Clinical trials for Oropharyngeal Dysphagia

Rehabilitation Manometry Study

Start date: November 11, 2020
Phase:
Study type: Observational

Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects physiological and psychosocial functioning in 1 in 25 adults. Many dysphagia treatments exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal high-resolution manometry (pHRM) directly measures swallowing pressures, providing an objective measurement of physiology that characterizes the basic mechanisms of swallowing. pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective, and reproducible measures of swallowing function. This proposed project will address a central hypotheses that objective swallowing measures (including (pHRM) will reveal treatment-mediated swallowing changes, will align with patient-reported outcome measures, and will be able to predict who will benefit from treatment. The investigators will follow a cohort of participants with oropharyngeal dysphagia as they undergo either pharyngeal strengthening therapy or relief of upper esophageal sphincter outlet obstruction at three time points: baseline, mid-treatment (4-6 weeks) and post-treatment (10-12 weeks). The investigators will compare participants to healthy controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient-reported outcome measures.

NCT ID: NCT03387267 Terminated - Stroke Clinical Trials

Videofluoroscopic Swallowing Study (VFSS)

PORSCHE
Start date: October 24, 2017
Phase: N/A
Study type: Interventional

The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.