Tokyo, Dec. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060047) titled 'A Study of Pressure Changes in the Throat and Esophagus During Swallowing' on Dec. 10.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Fujita Health University
Condition:
Condition - Healthy individuals and patients with dysphagia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to investigate the effects of bolus volume, bolus consistency, and swallowing maneuvers on pharyngeal and esophageal pressure during the swallowing reflex in healthy individuals and patients with dysphagia.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Swallowing maneuver
Interventions/Control_2 - Food texture
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Healthy participants: Individuals with no clinical evidence of feeding or swallowing dysfunction.
Patients with dysphagia: Hospitalized and ambulatory patients diagnosed with dysphagia.
Key exclusion criteria - Healthy participants: Abnormal findings in feeding or swallowing function on screening.
Patients with dysphagia: Severe dysphagia with inability to ingest food orally.
Target Size - 100
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2017 Year 01 Month 20 Day
Date of IRB - 2017 Year 01 Month 20 Day
Anticipated trial start date - 2017 Year 01 Month 20 Day
Last follow-up date - 2026 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068657
Disclaimer: Curated by HT Syndication.
