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Deglutition Disorders clinical trials

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NCT ID: NCT05551182 Not yet recruiting - Dysphagia Clinical Trials

Nicergoline Use in Dysphagia Patients

Start date: January 2023
Phase: Phase 3
Study type: Interventional

Dysphagia is a complication in patient with stroke, Parkinson's disease or dementia that can lead to aspiration pneumonia. This study aimed to investigate dysphagia improvement after treatment with nicergoline low dose and high dose, the relationship between nicergoline dose and clinical improvements, side effect of nicergoline and simulation optimal nicergoline dose in dysphagia improvement.

NCT ID: NCT05523973 Completed - Stroke, Ischemic Clinical Trials

Lingual Endurance Exercise in Treating Post-Stroke Dysphagia

Start date: August 2, 2022
Phase: N/A
Study type: Interventional

This study will enroll 15 participants in each exercise condition (groups described below). Aim 1: Determine feasibility of lingual endurance training for individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: patient adherence (# of attempted repetitions/# prescribed repetitions) and dose delivery (# of repetitions meeting goal/# prescribed repetitions). Aim 2: Determine efficacy of lingual endurance training on improving critical aspects of oropharyngeal swallowing (physiologic impairments, clearance of oropharyngeal residue, airway protection), functional oral intake, and patient reported swallowing quality of life in individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: improvement on videofluoroscopic assessment of swallowing function using the gold standard Modified Barium Swallowing Impairment Profile (MBSImP) Overall Impairment (OI) score and Functional Oral Intake Scale (FOIS) score. Secondary outcome measures: oropharyngeal residue - Normalized Residue Ratio Scale (NRRS); airway invasion - Penetration Aspiration Scale (PAS). Patient reported outcome measures: EAT-10 (Eating Assessment Tool) and the Swallowing Quality of Life Questionnaire (SWAL-QoL). Aim 3: Determine if lingual endurance training + transference exercise (Exercise Group #2) results in better transference of exercise effects to the aforementioned outcomes of swallow safety and efficiency (in Aim2).

NCT ID: NCT05516693 Recruiting - Swallowing Disorder Clinical Trials

Chewing, Swallowing and Orofacial Motricity in Severe Obese

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Background: Obesity is considered an epidemic disease of great repercussion on the world and its prevalence has increased in recent decades. The treatment of obesity aims to improve health and quality of life, by reducing body weight. The clinical approach to obesity is routinely the first line of treatment. Clinical treatment usually involves a combination of restriction of caloric intake, modification of behavior and habits, regular practice of physical activity and pharmacotherapy. Clinical treatment of obesity leads to considerable weight loss, but often not sustained in most patients. This long-term sustained weight loss is an attribute of bariatric surgery, since severe obesity remains largely refractory to dietary and drug therapy. Changes in lifestyle that occur in severely obese patients undergoing bariatric surgery, especially in terms of food, lead to the need for the contribution of speech therapy to adapt to the new way of ingesting food. Objectives: to analyze the stomatognathic functions of mastication and swallowing and to verify the effectiveness of orofacial motricity stimulation in adults, severely obese before and after bariatric surgery. Methods: This is a randomized, controlled clinical trial involving severely obese adult patients of both sexes referred for bariatric surgery. This study was approved by the Research Ethics Committee of the Centro Universitário Fundação Assis Gurgacz (FAG) in the city of Cascavel (PR), Brazil, protocol number CEP FAG no. 4,169,295. Patients will be consecutively recruited from the Bariatric Surgery Department of Hospital São Lucas (FAG) and referred to the Speech Therapy Clinic according to the eligibility criteria of the research protocol. After the initial assessment, patients will be randomly assigned to an intervention group (MOG) and a control group (COG). The COG and MOG groups will be evaluated before and after bariatric surgery. Only the GMO will be submitted to the speech therapy training program before bariatric surgery. The myofunctional characteristics will be evaluated through the Orofacial Myofunctional Assessment protocol with Scores (AMIOFE). The AMIOFE protocol was designed according to the assessment models that reflect the physical characteristics and orofacial behaviors of individuals. In this way, the components and functions of the stomatognathic system will be evaluated in terms of appearance/posture, mobility and swallowing functions - liquid and solid - chewing and breathing.

NCT ID: NCT05501015 Recruiting - Clinical trials for Post Extubation Dysphagia

Functional Oral-Pharyngeal Rehabilitation of Patients With Dysphagia Using Ice-chips, a Prospective Randomized Study

Start date: May 2, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the effectiveness of early swallowing intervention in post extubated patients in the ICU to determine if this minimizes the risk of aspiration, increases initiating of oral intake sooner, reduced length of ICU stay and reduces the need for alternate means of nutrition/hydration. Patients will be randomly assigned to either Group A or B. We will decide grouping, using wheel that will randomly select group A or B after spinning. All participants will receive ongoing therapy while enrolled in the study until they receive an oral diet or are placed on a feeding tube as directed by their physician. Participants will be assigned to be in Group A or B. In Group A, participants will receive traditional swallowing therapy and perform exercises to strengthen swallowing muscles three times a day, while in Group B, participants will consume ice chips with supervision three times a day, which is also to strengthen swallowing muscles. Before starting therapy, all participants will receive a Clinical Dysphagia Evaluation by a Speech-Language Pathologist and an instrumental swallowing assessment by a Speech-Language Pathologist called a Fiberoptic Endoscopic Evaluation of Swallowing -(FEES). The FEES is an objective exam where a small, thin fiberoptic endoscope is placed trans nasally by the SLP. The assessment determines if a patient is aspirating, what texture of food and /or liquid the patient is aspirating, assesses ability to manage secretions, assesses vocal fold movement and determines if patient is safe to begin oral intake. Group A will serve as the control group. This group will receive oral hygiene followed by traditional dysphagia exercises, including effortful swallow, Masako Maneuver, and Tongue Press. This will occur three times a day. Group B will serve as the experimental group. In place of traditional dysphagia exercises, participants in Group B will receive oral hygiene and will consume small amounts of ice chips with supervision, three times a day. The ice chip protocol is based on the same findings as the Frazier Free Water Protocol, in that small amounts of clean water or ice chips are not harmful to the lungs and relatively benign if aspirated. Ice chips provide additional advantages in rehabilitating dysphagia as they are a cohesive bolus that are easier for patients with severe dysphagia to control in their mouth and swallow.

NCT ID: NCT05497947 Completed - Swallowing Disorder Clinical Trials

Evaluation of the French Translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) After Total PharyngoLaryngectomy

SOAL-VF
Start date: July 3, 2021
Phase:
Study type: Observational

A monocentric study to evaluate the french translation of Swallowing (SOAL-VF) Patient Reported Outcomes (PRO) after Total PharyngoLaryngectomy

NCT ID: NCT05497219 Enrolling by invitation - Clinical trials for Dysphagia, Oropharyngeal

Reference Values for Videofluoroscopic Measures of Swallowing

NIA_RV
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

Dysphagia (swallowing impairment) is a serious health condition seen in many age-related disease and injury processes. Although videofluoroscopy (VF) is an international "gold standard" dysphagia diagnostic exam, there is a paucity of available normative physiologic VF reference values in healthy adults across the age span to guide interpretation of these examinations. In this project, the investigators will extend previous work on the quantitative measurement of swallowing physiology from VF examinations to establish reference values for swallowing in healthy adults, and to identify clinical decision point values for differentiating healthy swallowing across the age span from disordered swallowing in several high-risk clinical populations to study dysphagia.

NCT ID: NCT05484726 Recruiting - Preterm Birth Clinical Trials

Maternal Role in Oral Feed Establishment in Preterm Neonates

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will 1. Start taking oral feed at the same time as compared to control group 2. Take the same amount of milk at the commencement of oral feeding 3. Take milk with equal efficiency 4. Not face more adverse effects

NCT ID: NCT05483582 Recruiting - Dysphagia Clinical Trials

Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

This study is a pilot study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders. The purpose of this study is to investigate the difference in effect by the electric stimulation method and to obtain the values such as mean, standard deviation and so on, and to determine the number of subjects to be studied for clinical trials of validation permission in the future.

NCT ID: NCT05473169 Not yet recruiting - Swallowing Disorder Clinical Trials

Swallowing Evaluation in VF Immobility

Start date: July 2022
Phase:
Study type: Observational

Vocal fold immobility (VFI) often results in significant problems with dysphonia, dysphagia, and decreased cough strength. As one element of the dysphagia potentially associated with vocal fold immobility, aspiration may create significant morbidity for these patients. An estimated 38% to 53% of patients with untreated VFI have swallowing difficulties with aspiration. Vocal fold immobility has important implication on the laryngeal airway protection during respiration, phonation and swallowing. It is the most common neurological laryngeal disorder. The immobility may be caused by neck and thoracic surgery. which can impair the innervation of the pharynx, upper esophageal sphincter (U.E.S) and proximal esophagus but may also be due to malignancy,trauma, Intracranial causes,or may be idiopathic

NCT ID: NCT05439447 Recruiting - Clinical trials for Deglutition Disorders

A Study on Building a Voice Cohort for the Development of a Non-face-to-face Machine Learning Diagnostic and Monitoring Platform Using Voice Analysis and Various Sensors in Patients With Dysphagia.

Start date: October 7, 2022
Phase:
Study type: Observational

Collection of basic data for real-time analysis and monitoring by measuring what changes in voice occur according to the state of dysphagia using voice analysis and various sensors.