UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060311 |
|---|---|
| Receipt number | R000068991 |
| Scientific Title | Investigation of the Effects of Stochastic Resonance on Oral and Swallowing Function |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/01/09 14:33:52 |
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Basic information
Public title
Investigation of the Effects of Stochastic Resonance on Oral and Swallowing Function
Acronym
Investigation of the Effects of Stochastic Resonance on Oral and Swallowing Function
Scientific Title
Investigation of the Effects of Stochastic Resonance on Oral and Swallowing Function
Scientific Title:Acronym
Investigation of the Effects of Stochastic Resonance on Oral and Swallowing Function
Region
| Japan |
Condition
Condition
Dysphagia, Oral-hypofunction
Classification by specialty
| Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to conduct a pre-post interventional clinical study involving older adults with reduced swallowing function and patients with dysphagia. Specifically, we will evaluate changes in the cough reflex threshold, swallowing reflex latency and initiation site, tongue pressure, masticatory performance, two-point discrimination of the tongue, tongue roughness discrimination ability, and tongue tactile sensation, in order to investigate the effects of stochastic resonance noise vibration stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measures are changes in the cough reflex threshold, swallowing reflex latency, tongue-related functional parameters, and masticatory performance. The secondary outcome measures include the effects of baseline characteristics on the intervention outcomes.
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
| Device,equipment | Maneuver |
Interventions/Control_1
The cough reflex threshold, swallowing reflex latency and initiation site, tongue pressure, masticatory performance, two-point discrimination of the tongue, tongue roughness discrimination ability, monofilament test results, and tongue tactile function were measured at three time points: before the intervention (Pre), during the intervention (Mid), and after the intervention (Post), in order to evaluate immediate changes and short-term residual effects.
To prevent the measurement results of each parameter from being influenced by other assessments, the three-stage measurements (Pre, Mid, and Post) for each parameter were performed consecutively, followed by the measurements of the next parameter. This measurement sequence minimizes interference among different assessment items and enables a more accurate evaluation of the immediate and short-term effects of stochastic resonance stimulation.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must be able to understand the study procedures, voluntarily agree to participate, and provide written informed consent.
Participants must have intact cognitive function, defined as a Clinical Dementia Rating (CDR) score of 0, and be able to sufficiently understand the experimental instructions and perform the assessments of oral, tongue, and masticatory functions as instructed.
Participants must have oral and tongue functions that allow participation in the vibration stimulation experiment, including basic sensory and motor abilities of the tongue.
Key exclusion criteria
Individuals with cognitive or psychiatric impairments, including severe cognitive impairment, severe psychiatric disorders, or alcohol or drug dependence, who are unable to understand the experimental instructions or complete the measurements.
Individuals taking medications that may affect oral sensation or tongue muscle function, such as sedatives, anesthetics, or muscle relaxants.
Any other individuals deemed unsuitable for participation by the principal investigator, including those with markedly poor general health or a limited life expectancy.
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Kanako |
| Middle name | |
| Last name | Yoshimi |
Organization
Institute of Science Tokyo
Division name
Department of Dysphasia rehabilitation, Division of Medical and Dental Sciences, Graduate school of ISCT
Zip code
1138549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5562
k.yoshimi.gerd@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Yoshimi |
Organization
Institute of Science Tokyo
Division name
Department of Dysphasia rehabilitation, Division of Medical and Dental Sciences
Zip code
1138549
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5562
Homepage URL
k.yoshimi.gerd@tmd.ac.jp
Sponsor or person
Institute
Others
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee of Institute of Science Tokyo
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4547
info.bec@tmd.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 | 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
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 | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | 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 | 01 | Month | 09 | Day |
Last modified on
| 2026 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068991
