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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018047
Receipt No. 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

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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
Email 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
Email kyoshito@shinshu-u.ac.jp

Sponsor
Institute Department of Dentistry and Oral Surgery, Shinshu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020845

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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