UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040253
Receipt No. R000045897
Scientific Title The research on improvement of tongue movement using oral appliance
Date of disclosure of the study information 2020/04/27
Last modified on 2020/10/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The research on improvement of tongue movement using oral appliance
Acronym The research on improvement of tongue movement using oral appliance
Scientific Title The research on improvement of tongue movement using oral appliance
Scientific Title:Acronym The research on improvement of tongue movement using oral appliance
Region
Japan

Condition
Condition Swallowing disorder
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of swallowing function by the oral appliance for low tongue rest position.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tong pressure, Oral diadokokinesis, Repetitive saliva swallowing test, Modified water swallowing test, Food test, Cough test, Penetration aspiration scale
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 To apply the oral appliance for treatment
Interventions/Control_2 To apply the oral appliance without treatment effect
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
100 years-old >
Gender Male and Female
Key inclusion criteria Male and female aged over 65 who take dysphagia rehabilitation treatment at Dental Hospital, nursing home, welfare facility, or patient's home.
Key exclusion criteria Those who have poor general condition, disturbance of unconsciousness, dementia, bulbar paralysis, or experience of temporomandibular joint disorder, asthma, any disease causing swallowing disorder which is progressive or not stable, or oropharyngeal surgery caused swallowing disorder.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Hara
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Dysphagia Rehabilitation
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-Ward, Tokyo
TEL 03-5803-5562
Email koji19831031@gmail.com

Public contact
Name of contact person
1st name Koji
Middle name
Last name Hara
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Dysphagia Rehabilitation
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-Ward, Tokyo
TEL 03-5803-5562
Homepage URL
Email koji19831031@gmail.com

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-Ward, Tokyo
Tel 03-5803-4085
Email info.bec@tmd.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
2020 Year 04 Month 27 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 Enrolling by invitation
Date of protocol fixation
2020 Year 04 Month 27 Day
Date of IRB
2020 Year 09 Month 28 Day
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2022 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
2020 Year 04 Month 27 Day
Last modified on
2020 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045897

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.