UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The influence of the training using the tongue attachment
Title of the study (Brief title)	The influence of the training using the tongue attachment
Region	Japan

Condition
Condition	healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of the effect of the tongue attachment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Phase I

Assessment
Primary outcomes	Before and after the wearing of the device Oral cavity function evaluation
Key secondary outcomes	Evaluation of swallowing function

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	put on a tongue attachment and carry out training
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	healty adults
Key exclusion criteria	Person with the functional disorder of the tongue Person who has a wound to a tongue
Target sample size	20

Research contact person
Name of lead principal investigator	haruka tohara
Organization	tokyo medical and dental university
Division name	gerodontology
Address	1-5-45 yushima bunkyo-ku 113-8549 japan
TEL	03-5803-5750
Email	haruka-t@rd5.so-net.ne.jp

Public contact
Name of contact person	marie sato
Organization	tokyo medical and dental university
Division name	gerodontology
Address	1-5-45 yushima bunkyo-ku 113-8549 japan
TEL	03-5803-5560
Homepage URL
Email	sato.ohp@tmd.ac.jp

Sponsor
Institute	tokyo medical and dental university
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東京医科歯科大学歯学部付属病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 01 Month 15 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 10 Day
Last modified on	2017 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029466