UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053302 |
|---|---|
| Receipt number | R000060837 |
| Scientific Title | Investigation of changes in food texture by transcutaneous electrical nerve stimulation of salivary glands |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2025/04/02 08:34:08 |
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Basic information
Public title
Investigation of changes in food texture by transcutaneous electrical nerve stimulation of salivary glands
Acronym
Investigation of changes in texture induced by electrical stimulation of salivary glands
Scientific Title
Investigation of changes in food texture by transcutaneous electrical nerve stimulation of salivary glands
Scientific Title:Acronym
Investigation of changes in food texture by transcutaneous electrical nerve stimulation of salivary glands
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of transcutaneous electrical stimulation to salivary glands on the sensation of humidity in food by stimulating saliva secretion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The participants were asked to select the bread with the closest humidity during the electric stimulation.
The subjective humidity of the bread during the electrical stimulation was evaluated using a Visual Analogue Scale.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
With transcutaneous electrical stimulation
Interventions/Control_2
Without transcutaneous electrical stimulation
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subjects between 20 and 65 years of age who will participate in the experiment of their own free will.
Key exclusion criteria
Patients with heart disease, neurological disease, brain disease, and respiratory failure. Pregnant women, women who may become pregnant, and women who have a skin rash caused by alcohol. Patients with allergic diseases (including food, metal, and alcohol, but excluding hay fever), patients with skin damage, inflammation, or other abnormalities at the electrode placement site, patients prone to internal bleeding such as purpura, patients with malignant tumors, patients with sensory disturbance, hypertension, patients with skin rash caused by biological tape, patients with pacemakers or other implanted devices, and patients with any health concerns. Those who have some concerns about their health, such as those who use implanted devices such as pacemakers
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuma |
| Middle name | |
| Last name | Aoyama |
Organization
Gunma University
Division name
Faculty of Informatics
Zip code
371-0044
Address
4-2, Aramaki, Maebashi, Gunma, Japan
TEL
027-220-7572
aoyama@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Aoyama |
Organization
Gunma University
Division name
Faculty of Informatics
Zip code
371-0044
Address
4-2, Aramaki, Maebashi, Gunma, Japan
TEL
027-220-7572
Homepage URL
aoyama@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Japan Society for The Promotion Science
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
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15, Showa, Maebashi, Gunma, Japan
Tel
027-220-7111
hitotaisho-ciru@ml.gunma-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
| 2024 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
The results suggest that the subjective sense of humidity in the mouth, as measured using the Visual Analogue Scale, is enhanced by transcutaneous electrical stimulation of the salivary glands.
On the other hand, the results of the choice method suggest that the sense of humidity does not change with or without electrical stimulation.
Results date posted
| 2025 | Year | 04 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 24 | 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
| 2024 | Year | 01 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060837
