UMIN-CTR Clinical Trial

Basic information
Public title	Development a swallowing training system for ameliorating dysphagia using intraoral electric potentials in the oral cavity.
Acronym	Development a swallowing training system for ameliorating dysphagia using intraoral electric potentials in the oral cavity.
Scientific Title	Development a swallowing training system for ameliorating dysphagia using intraoral electric potentials in the oral cavity.
Scientific Title:Acronym	Development a swallowing training system for ameliorating dysphagia using intraoral electric potentials in the oral cavity.
Region	Japan

Condition
Condition	dysphagia
Classification by specialty	Oto-rhino-laryngology Oral surgery Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We measure the electric potential in the oral cavity. We estimate the tongue motion from the measured potentials and develop a visual feedback system using the estimation results. We evaluate the effect of the system on tongue exercise to adults.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We evaluate the visual feedback effect of the estimation results of the tongue exercise using Fitts' law.
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	1.Feedback training is participated. 2.The training period is less than one hour. 3.After the training, participants are evaluated the tongue movement performance.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	People 1) 20 years-old or older and under 65 years-old. 2) does not have the ingestion/swallow difficulty.
Key exclusion criteria	Peaple 1) undergoing dental treatment. 2) with an injury on the oral cavity or tongue. 3) with metal allergy 4) with alcohol Intolerance 5) after alcohol consumption 6) uses cardiac pacemaker. 8) with infectious disease or Malignant tumors. 9) with bleeding diathesis 10) with 37 Celsius degree or higher body temperature 11) with 180 mm/Hg or higher of the systolic pressure and 90 mm/Hg or lower of the lowest blood pressure. 12) whose heart rate is 100 beats or more or less than 40 beats. 13) yanger than 20 years-old and older than 65 years-old. 14) who judged to inappropriate.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Shintaro Middle name Last name Nakatani
Organization	Tottori University
Division name	Graduate School of Engineering
Zip code	6808552
Address	101, 4 Cho-me, Koyama-cho Minami, Tottori 680-8550 Japan
TEL	0857-31-5835
Email	snakatani@mech.tottori-u.ac.jp

Public contact
Name of contact person	1st name Shintaro Middle name Last name Nakatani
Organization	Tottori University
Division name	Graduate School of Engineering
Zip code	6808552
Address	101, 4 Cho-me, Koyama-cho Minami, Tottori 680-8550 Japan
TEL	0857-31-5835
Homepage URL
Email	snakatani@mech.tottori-u.ac.jp

Sponsor
Institute	Tottori University
Institute
Department

Funding Source
Organization	Japan Society for the promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Tottori University
Address	4-101, Koyama-cho Minami, Tottori-shi, Tottori 680-8552 Japan
Tel	0857315835
Email	snakatani@tottori-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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 24 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
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	Main results already published
Date of protocol fixation	2017 Year 06 Month 08 Day
Date of IRB	2018 Year 07 Month 04 Day
Anticipated trial start date	2018 Year 06 Month 16 Day
Last follow-up date	2023 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	2017 Year 06 Month 23 Day
Last modified on	2022 Year 06 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031439