UMIN-CTR Clinical Trial

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
Last 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
1st 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