UMIN-CTR Clinical Trial

Basic information
Public title	Experimental study on variation of speech rate and Japanese articulation using electro paratography (EPG)
Acronym	Experimental study on variation of speech rate and Japanese articulation using electro paratography (EPG)
Scientific Title	Experimental study on variation of speech rate and Japanese articulation using electro paratography (EPG)
Scientific Title:Acronym	Experimental study on variation of speech rate and Japanese articulation using electro paratography (EPG)
Region	Japan

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

Objectives
Narrative objectives1	In this research, we investigate the relation between the type of sound and the speech speed in Japanese articulation using EPG. It is aimed to analyze the tongue motion during articulation by extracting the change of the tongue and palate contact caused by speaking with various sounds and by changing the speech speed.
Basic objectives2	Others
Basic objectives -Others	Change of tongue motion during articulation due to change of speech speed is clarified.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EPG data.
Key secondary outcomes

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	Prevention
Type of intervention	Other
Interventions/Control_1	Randomly pronounce words and short sentences five times at a time, and record voice and EPG data.
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	1) Those who speak their mother tongue in Japanese 2) Person who possesses certain knowledge about pronunciation and can perform subjective control 3) In cooperation with research cooperation, you can express your intention to research cooperation by yourself, those who obtain written consent with free will of the target
Key exclusion criteria	1) Persons with trauma in the oral cavity
Target sample size	3

Research contact person
Name of lead principal investigator	1st name Middle name Last name shohei okumura
Organization	Graduate school of Health Sciences, Osaka Health Science University
Division name	Graduate course of Health Science
Zip code
Address	1-9-27, Temma, Kita-ku Osaka-shi, Osaka, 530-0043, Japan
TEL	06-6352-0093
Email	u1781002@ohsu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name shohei okumura
Organization	Graduate school of Health Sciences, Osaka Health Science University
Division name	Graduate course of Health Science
Zip code
Address	1-9-27, Temma, Kita-ku Osaka-shi, Osaka, 530-0043, Japan
TEL	06-6352-0093
Homepage URL
Email	u1781002@ohsu.ac.jp

Sponsor
Institute	Graduate school of Health Sciences, Osaka Health Science University
Institute
Department

Funding Source
Organization	Graduate school of Health Sciences, Osaka Health Science University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 05 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
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 09 Month 05 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 05 Day
Last modified on	2018 Year 12 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038803

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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