UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060201 |
|---|---|
| Receipt number | R000068844 |
| Scientific Title | Elicitation of the Swallowing Reflex by Esophageal Water Stimulation: An Evaluation Using High-Resolution Manometry |
| Date of disclosure of the study information | 2025/12/25 |
| Last modified on | 2025/12/25 13:09:02 |
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Basic information
Public title
A Study of the Swallowing Reflex and Pressure Changes Induced by Esophageal Water Stimulation
Acronym
EWSR Study
Scientific Title
Elicitation of the Swallowing Reflex by Esophageal Water Stimulation: An Evaluation Using High-Resolution Manometry
Scientific Title:Acronym
EWSR-HRM Study
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of the swallowing reflex induced by esophageal stimulation, confirmed by high-resolution pharyngo-esophageal manometry
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
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.)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 100 | 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 sample size
100
Research contact person
Name of lead principal investigator
| 1st name | HIROSHIGE |
| Middle name | |
| Last name | TANIGUCHI |
Organization
Asahi University
Division name
Department of Dysphagia Rehabilitation, Division of Oral Pathogenesis and Disease Control, School of Dentistry
Zip code
5008523
Address
3-23 Hashimoto-cho, Gifu City, Gifu
TEL
0582538001
h-taniguchi@dent.asahi-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROSHIGE |
| Middle name | |
| Last name | TANIGUCHI |
Organization
Asahi University
Division name
Department of Dysphagia Rehabilitation, Division of Oral Pathogenesis and Disease Control
Zip code
5008523
Address
3-23 Hashimoto-cho, Gifu City, Gifu
TEL
0582538001
Homepage URL
h-taniguchi@dent.asahi-u.ac.jp
Sponsor or person
Institute
Asahi University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahi University
Address
1851 Hozumi Mizuho Gifu 501-0296, Japan
Tel
0583291111
h-taniguchi@dent.asahi-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068844
