UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018047 |
|---|---|
| Receipt number | R000020845 |
| Scientific Title | Study on sensing swallowing muscle activity and application to swallowing supplements |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2019/03/31 08:01:48 |
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Basic information
Public title
Study on sensing swallowing muscle activity and application to swallowing supplements
Acronym
Measuring Muscle Activities by using Electromyography Electrodes Attached to a Sheet
Scientific Title
Study on sensing swallowing muscle activity and application to swallowing supplements
Scientific Title:Acronym
Measuring Muscle Activities by using Electromyography Electrodes Attached to a Sheet
Region
| Japan |
Condition
Condition
swallowing disorder
Classification by specialty
| Neurology | Oral surgery | Rehabilitation medicine |
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are aiming at preventing aspiration and realizing a safe meal in hospital and welfare facilities through noninvasive procedure for evaluating swallowing function by using sensing technology.
Basic objectives2
Others
Basic objectives -Others
In order to measure muscle activities during swallowing in a non-invasive and easy method, we propose the sensor sheet that consist of multiple electromyography electrodes.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relation between the EMG and the VF data of swallow muscular activity
Key secondary outcomes
safety
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
A subject has a VF examination at the same time with measurement of a sensor seat.
About 2 healthy volunteers are performed as spare clinical study for the grade of the safety. After that 3 healthy volunteers are added for comparison as this research and 6 swallow obstacle patients who had VF request are performed.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
[healthy volunteer selection reference]
(1) More than 20-year-old men and women by whom a swallow obstacle isn't expected.
(2) Men and women of more than 3 times of repetition saliva swallow test and more than 4 revise glass tests.
(3) The men and women who don't have the past of aspiration pneumonia.
[Patient selection reference]: following all is satisfied.
(1) More than 20-year-old patient who diagnosed a swallow obstacle or was expected
(2) The patient who had operation request of a VF check in special dentistry and a dental oral surgery (A request family doesn't care.)
(3) The back and the patient who could get consent by a document based on free will of the patient person himself which had the enough explanation in case of participation in this research
Key exclusion criteria
[Patient and healthy volunteer exclusion criteria]: following
(1) Patient after a pacemaker embedded operation (healthy man)
(2) The patient who admits dermatitis of Grade more than 2 (Something to choose as radiation is also included.) (healthy man)
(3) The patient who admits allergy to barium (healthy man)
(4) By consciousness disorder, the lack of sleep and pneumonia, the patient with the not good whole body state (healthy man)
(5) Enteron perforation, the fear and the patient who doubts, bleeds acutely in an enteron, doubts an enteron blockade or the fear* and has the medical history of the hyperesthesia by the medical history of the hyperesthesia, a book pill ingredient or a component by a similar drug (healthy man)
(6) The patient with a high possibility of the appearance of the skin symptom which are contact dermatitis, pruritus, eczema, erythema and subcutaneous bleeding, etc. by a sticking pill (healthy man)
(7) Pregnant woman or female patient with a possibility of the pregnancy (healthy man)
(8) Additionally the patient who judged that a study person in charge was unsuitable as a subject (healthy man)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Koyama |
Organization
Shinshu University School of Medicine
Division name
Department of Dentistry and Oral Surgery
Zip code
3908621
Address
Asahi3-1-1, Matsumoto City, Nagano
TEL
0263-37-2677
kyoshito@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshito |
| Middle name | |
| Last name | Koyama |
Organization
Shinshu University
Division name
Department of Dentistry and Oral Surgery
Zip code
3908621
Address
Asahi3-1-1, Matsumoto City, Nagano
TEL
0263-37-2677
Homepage URL
kyoshito@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Dentistry and Oral Surgery, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Public Management, Home Affairs, Posts and Telecommunications
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagano Prefecture General Industrial Technology Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
shinshu
Address
Asahi3-1-1, Matsumoto City, Nagano
Tel
0263373572
mdrinri@shinshu-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
信州大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
31
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
| 2015 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2015 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020845
