UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059906 |
|---|---|
| Receipt number | R000068517 |
| Scientific Title | Swallowing Function Assessment Using a Neck-Worn Electronic Stethoscope |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/11/27 19:07:53 |
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Basic information
Public title
Swallowing Function Assessment Using a Neck-Worn Electronic Stethoscope
Acronym
Swallowing Function Assessment Using a Neck-Worn Electronic Stethoscope
Scientific Title
Swallowing Function Assessment Using a Neck-Worn Electronic Stethoscope
Scientific Title:Acronym
Swallowing Function Assessment Using a Neck-Worn Electronic Stethoscope
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate swallowing function in patients with dysphagia using a neck worn electronic stethoscope and to clarify its validity and efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of Swallowing Sounds, Swallowing Frequency, and Signs of Aspiration
Correlation analysis between patient background factors and swallowing monitor evaluation
Key secondary outcomes
Comparative Analysis with Endoscopic Swallowing Examination Findings
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Using a neck worn electronic stethoscope
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
| 5 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with dysphagia
Key exclusion criteria
Patients with severe cognitive impairment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kento |
| Middle name | |
| Last name | Ko |
Organization
Toyama University Hospital
Division name
Department of Otorhinolaryngology,Head and Neck Surgery
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama
TEL
076-434-2281
kentoko@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Ko |
Organization
Toyama University Hospital
Division name
Department of Otorhinolaryngology, Head and Neck Surgery
Zip code
930-0194
Address
2630 Sugitani, Toyama City, Toyama
TEL
076-434-2281
Homepage URL
kentoko@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama Univeristy
Institute
Department
Personal name
Funding Source
Organization
Toyama University
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
Ethics Committee, University of Toyama
Address
3190 Gofuku,Toyama City, Toyama
Tel
076-415-8857
kenrinri@adm.u-toyama.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
富山大学附属病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068517
