UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study on tongue pressure and the tongue base-lifting muscle activity during articulation,chewing and swallowing in elderly people.
Acronym	Exploratory study on tongue pressure and the tongue base-lifting muscle activity in elderly people.
Scientific Title	Exploratory study on tongue pressure and the tongue base-lifting muscle activity during articulation,chewing and swallowing in elderly people.
Scientific Title:Acronym	Exploratory study on tongue pressure and the tongue base-lifting muscle activity in elderly people.
Region	Japan

Condition
Condition	dysphagia frailty
Classification by specialty	Rehabilitation medicine Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the relationship between the muscle activity of the tongue base that occurs at the time of articulatory, mastication and swallowing in the elderly, evaluate swallowing function and masticatory function, and
Basic objectives2	Others
Basic objectives -Others	To compare and examine EMG data of elderly people and young people, and clarify the characteristics of elderly people.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Muscle activity of tongue base-lifting activity at the time of the intervention
Key secondary outcomes	Onset and offset timing of the muscle activity, muscle activity continuation time at the time of the intervention

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	Prevention
Type of intervention	Other
Interventions/Control_1	Perform EMG recording under the following conditions. 1)articulation 2)chewing and swallowing. Perform oral and swallowing function evaluation.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elderly people using removable dentures for unilateral free end space in either upper or lower jaw.
Key exclusion criteria	When a subjects corresponds to any of the following items, he/she is excluded from this study; 1)Allergy to alcohol antiseptic solution 2)Dysphagia 3)In addition, those judged to be inappropriate by the research director and the research sharing person as subjects
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yousuke Middle name Last name manda
Organization	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6687
Email	y.manda@s.okayama-u.ac.jp

Public contact
Name of contact person	1st name Yousuke Middle name Last name Manda
Organization	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Zip code	700-8558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-6687
Homepage URL
Email	y.manda@s.okayama-u.ac.jp

Sponsor
Institute	Okayama university
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
Tel	086-235-6687
Email	mae6605@adm.okayama-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	2019 Year 10 Month 01 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	Preinitiation
Date of protocol fixation	2019 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date	2019 Year 09 Month 26 Day
Last follow-up date	2021 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	2019 Year 07 Month 21 Day
Last modified on	2019 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042677