Tokyo, Dec. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060201) titled 'A Study of the Swallowing Reflex and Pressure Changes Induced by Esophageal Water Stimulation' on Dec. 25.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Asahi University

Condition: Condition - Dysphagia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to evaluate the safety and effectiveness of eliciting the swallowing reflex by esophageal liquid stimulation in older healthy individuals and patients with dysphagia using high-resolution pharyngo-esophageal manometry, and to identify the stimulation conditions that most effectively induce the swallowing reflex. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Water is infused into the esophagus via a transnasally inserted catheter to elicit the swallowing reflex (swallowing activity). The occurrence of induced swallowing and pharyngo-esophageal pressure responses are assessed using high-resolution manometry. (Infusion volume, rate, infusion site, and number of trials are predefined in the protocol.)

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - Individuals who have received sufficient explanation of the study overview, objectives, procedures, and ethical considerations, and who have provided written informed consent.

Individuals who meet one of the following criteria: Older healthy participants (n = 20). Inpatients or outpatients with dysphagia (n = 50). Key exclusion criteria - Individuals with current or past esophageal diseases, including gastroesophageal reflux disease (GERD).

Individuals deemed inappropriate for participation in this study by the principal Target Size - 100

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2024 Year 10 Month 05 Day Date of IRB - 2024 Year 10 Month 29 Day Anticipated trial start date - 2026 Year 01 Month 10 Day Last follow-up date - 2030 Year 03 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068844

Disclaimer: Curated by HT Syndication.