UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060668 |
|---|---|
| Receipt number | R000069388 |
| Scientific Title | Evaluation of swallowing function by simultaneous measurement of laryngeal motion, electromyography of the suprahyoid muscles, and swallowing sounds |
| Date of disclosure of the study information | 2026/02/16 |
| Last modified on | 2026/02/13 16:16:07 |
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Basic information
Public title
Assessment of swallowing function by measuring throat motion, submandibular muscle activity, and swallowing sounds
Acronym
Biometrics-based assessment of swallowing function
Scientific Title
Evaluation of swallowing function by simultaneous measurement of laryngeal motion, electromyography of the suprahyoid muscles, and swallowing sounds
Scientific Title:Acronym
Biometircs-based evaluation of swallowing function
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Oto-rhino-laryngology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to simultaneously measure anterior neck movement (laryngeal movement), activity of the suprahyoid muscles, and swallowing sounds when swallowing a tablet, and to analyze the results to clarify differences in swallowing dynamics depending on the characteristics of the tablet (size, shape, coated or not coated) and the number of tablets.
Basic objectives2
Others
Basic objectives -Others
Another purpose of this study is to confirm the operation and performance of the newly developed measurement and analysis system for swallowing dynamics.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Study Methods and Design
Anterior neck movement, activity of the suprahyoid muscles, and swallowing sounds were simultaneously measured during tablet swallowing of study subjects in order to investigate the relationship between tablet characteristics and the number of tablets, and swallowing dynamics. The study design was a minimally invasive intervention study, due to minor invasiveness to the study subjects. The trial design was a crossover study. The measurement method was non-invasive biometrics. The evaluation method was data analysis and statistical analysis.
2. Study Subjects
- Male subjects aged 18 to 28 years old without significant swallowing problems.
- Planned Number of subjets: 10, because this is a pilot study to evaluate a newly developed measurement and analysis system.
- Experimental Period: One month.
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects swallow one or two tablets with 20ml of water.
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
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Male
Key inclusion criteria
-No particular problems were observed with swallowing function.
-Be covered by the Student Education and Research Accident Insurance or equivalent insurance.
Key exclusion criteria
-Persons who Feel great psychological stress or discomfort during the experiment.
-Persons who have trouble disinfecting their skin with alcohol or applying adhesive tape.
-Persons who become ill or are unable to swallow any more during the experiment.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Hayashi |
Organization
Niigata University
Division name
Interdisciplinary Program of Biomedical Engineering, Assistive Technology, and Art and Sports Sciences, Faculty of Engineering
Zip code
950-2181
Address
2-8050, Ikarashi, Nishi-Ku, Niigata
TEL
025-262-6756
thayashi@eng.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Toyohiko |
| Middle name | |
| Last name | Hayashi |
Organization
Niigata University
Division name
Faculty of Engineering
Zip code
950-2022
Address
2-8050, Ikarashi, Nishi-Ku, Niigata
TEL
090-8021-8321
Homepage URL
hayashi@eng.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
FANCL CORPORATION
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata Univeristy
Address
2-8050, Ikarashi,
Tel
090-8021-8321
hayashi@eng.niigata-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
| 2026 | Year | 02 | Month | 16 | 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
10
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 13 | Day |
Last modified on
| 2026 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069388
