UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022745 |
|---|---|
| Receipt number | R000026202 |
| Scientific Title | Effect of transcutaneous electrostimulation to swallowing muscles, masticatory muscles and saliva grands #1 Subjective assessment and amount of resting saliva |
| Date of disclosure of the study information | 2016/06/15 |
| Last modified on | 2019/03/20 16:12:59 |
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Basic information
Public title
Effect of transcutaneous electrostimulation to swallowing muscles, masticatory muscles and saliva grands
#1 Subjective assessment and amount of resting saliva
Acronym
Effect of electrostimulation on swallowing and masticatory muscles, and saliva grands
Scientific Title
Effect of transcutaneous electrostimulation to swallowing muscles, masticatory muscles and saliva grands
#1 Subjective assessment and amount of resting saliva
Scientific Title:Acronym
Effect of electrostimulation on swallowing and masticatory muscles, and saliva grands
Region
| Japan |
Condition
Condition
none (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the change of subjective assessment and amount of resting saliva after transcutaneous electrostimulation to swallowing muscles, masticatory muscles and saliva grands of healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
amount of resting saliva (pre, post, and 10 minutes after the intervention)
Key secondary outcomes
subjective assessment of physical condition (after the intervention)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
15 minutes electrostimulation on both masseter muscles and submandibular region with HV-F5200 (ME approval number: 220AGBZX00027000, OMURON Corporation)
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who give informed consent of participation before the study
Key exclusion criteria
Those who do not give informed consent of participation before the study
Those who are decided to be unsuitable as a participant by the chief experimenter
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Miwa |
| Middle name | |
| Last name | Matsuyama |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of Oral Health Care and Rehabilitation
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima-shi, 770-8504, JAPAN
TEL
088-633-9213
miwa.matsuyama@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Matsuyama |
Organization
Institute of Biomedical Sciences, Tokushima University Graduate School
Division name
Department of Oral Health Care and Rehabilitation
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima-shi, 770-8504, JAPAN
TEL
088-633-9213
Homepage URL
miwa.matsuyama@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Oral Health Care and Rehabilitation,
Institute of Biomedical Sciences, Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
MEXT
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
Clinical Research Review Board of Tokushima University
Address
2-50-1, Kuramoto-cho, Tokushima-shi, 770-8503, JAPAN
Tel
088-633-7958
brinshoshienk@tokushima-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
徳島大学大学院医歯薬学研究部（徳島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 15 | 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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2016 | Year | 06 | Month | 15 | Day |
Last modified on
| 2019 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026202
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
