UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061123 |
|---|---|
| Receipt number | R000069913 |
| Scientific Title | Examination of the effects of gargling with solutions of different viscosities on the activity of the suprahyoid muscles |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/04/01 11:27:34 |
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Basic information
Public title
A study investigating the muscle activity involved in gargling
Acronym
A study investigating the muscle activity involved in gargling
Scientific Title
Examination of the effects of gargling with solutions of different viscosities on the activity of the suprahyoid muscles
Scientific Title:Acronym
Examination of the effects of gargling with solutions of different viscosities on the activity of the suprahyoid muscles
Region
| Japan |
Condition
Condition
healthy older adults
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of gargling with solutions of different viscosities on the suprahyoid muscles.
Basic objectives2
Others
Basic objectives -Others
Prevention and improvement of coughing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity of the suprahyoid muscles during gargling
Key secondary outcomes
Evaluation of the ease of use of the test product used for gargling, Oral function
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
| Behavior,custom |
Interventions/Control_1
Gargling with five liquids of different viscosities for 20 seconds each
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Those who understand the purpose of this study and provide informed consent
2.Those who have a tongue pressure of less than 30 kPa
3.Those who have at least 20 remaining teeth and 28 or more functional teeth
4.Those who do not have serious systemic diseases
Key exclusion criteria
1.Those with incomplete data
2.Those who are unable to gargle
3.Those with dysphagia
4.Those who are currently participating in another interventional study, have participated within the past 4 weeks, or are planning to participate
5.Those who have been diagnosed with oral hypofunction at a dental institution
6.Those who are undergoing oral function training at a dental institution or similar facility
7.Those with allergies to the ingredients of the test products
8.Those deemed ineligible for participation by the dentist (principal investigator or sub-investigators)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirohiko |
| Middle name | |
| Last name | Hirano |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-1141
hhirano@tmig.or.jp
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Shirobe |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-1141
Homepage URL
mshirobe@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Maki Shirobe
Funding Source
Organization
Sunstar Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tthe ethics committee of the Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-1141
rinsyoushiken@tmghig.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 | 04 | 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
30
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
| 2025 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | 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 | 04 | Month | 01 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069913
