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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033515
Receipt No. R000037196
Scientific Title Simple deglutition rating system by sensing of deglutition line activity -comparison of healthy subjects and patients with dysphagia-
Date of disclosure of the study information 2018/07/30
Last modified on 2019/03/31

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Basic information
Public title Simple deglutition rating system by sensing of deglutition line activity
-comparison of healthy subjects and patients with dysphagia-
Acronym sensing of deglutition line activity
Scientific Title Simple deglutition rating system by sensing of deglutition line activity
-comparison of healthy subjects and patients with dysphagia-
Scientific Title:Acronym sensing of deglutition line activity
Region
Japan

Condition
Condition dysphasia
Classification by specialty
Neurosurgery Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We have used noninvasive procedures to evaluate swallowing function with sensing technology to prevent aspiration and achieve safe meals in hospitals and welfare facilities. Here, we propose a noninvasive and simple method to measure muscle activities during swallowing using a sensor sheet consisting of multiple electromyography electrodes.
Basic objectives2 Others
Basic objectives -Others We make screening tool for dysphagia patients and healthy control subjects.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To develop a screening method to identify differences in deglutition activity between dysphagia patients and healthy control subjects.
Key secondary outcomes Comparison between deglutition activity and master of VF end-point in dysphagia patients

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Other
Interventions/Control_1 Electromyography was performed using a sensor sheet and deglutition sound microphone attached to the neck of the subjects. The inspection foods were water, 2% thickened water, jelly, pasty food, and 100% rice gruel.
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects were divided into the dysphagia patient group and physically healthy group based on evaluation of swallowing function.
Inclusion criteria for healthy volunteers:
1.Men and women with a repetition saliva swallow test score > 3 and modified water swallow test score > 4.
2.No history of aspiration pneumonia.
3.More than 60 years old.
4.Written informed consent to participate in the study.
Inclusion criteria for dysphasia:
1.Men and women with a repetition saliva swallow test score < 3 and modified water swallow test score < 4.
2.More than 60 years old.
3.Written informed consent to participate in the study.
Key exclusion criteria Exclusion criteria for healthy volunteers and dysphasia:
1.History of tracheotomy.
2.Inability to understand oral instructions.
3.Embedded pacemaker.
4.Dermatitis grade > 2 (also included as radiation)
5.Consciousness disorder, insufficient sleep, pneumonia, and poor general condition.
6.Enteric perforation, acute enteric bleeding, and enteric blockade, including suspected cases, and a medical history of allergy to the inspection foods.
7.Patients with high risk of skin symptoms, including contact dermatitis, pruritus, eczema, erythema, subcutaneous bleeding, etc., induced by the sensor sheet.
8.Pregnant or with the possibility of pregnancy.
9.Patients otherwise judged by the person in charge as unsuitable.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yoshito
Middle name
Last name Koyama
Organization Shinshu University Hospital 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 medical school of 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,
medical school of Shinshu university
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 university
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(長野県)
市立大町総合病院(長野県)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 30 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 60
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
2018 Year 01 Month 20 Day
Date of IRB
2018 Year 01 Month 16 Day
Anticipated trial start date
2018 Year 01 Month 20 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
2018 Year 07 Month 25 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=R000037196

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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