UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051475 |
|---|---|
| Receipt number | R000058721 |
| Scientific Title | A comparative study on the effect of a new singing training on oral functions. |
| Date of disclosure of the study information | 2023/06/29 |
| Last modified on | 2024/01/29 21:33:24 |
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Basic information
Public title
A comparative study on the effect of a new singing training on oral functions.
Acronym
A comparative study on the effect of a new singing training on oral functions.
Scientific Title
A comparative study on the effect of a new singing training on oral functions.
Scientific Title:Acronym
A comparative study on the effect of a new singing training on oral functions.
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effectiveness of the singing training as a training method to improve oral functions. We will also examine whether this training can be used as a new swallowing training method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic information (age, sex, medical history, height, weight, occupation)
Swallowing function survey using the swallowing screening questionnaire (EAT-10)
Jaw opening strength
Oral diadochokinesis
Tongue pressure
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
singing songs
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects of this study will be men and women over 40 years old who are independent in ADL (Barthel index 85 or higher) and healthy without dysphagia. The total number of subjects will be 30, who gave their consent to participate in the study, from the website of the a cappella unit XUXU, which wrote the lyrics and composed the song "Patakarakarasu".
Key exclusion criteria
(1) Patients who have a progressive disease that causes dysphagia.
(2) Those with impaired consciousness, dementia, or other conditions that make it difficult to follow instructions.
(3) Those who are in a nursing home (public or private facilities excluding residential facilities) or is hospitalized.
Patients who meet any of the above conditions (1) to (3) will be excluded from the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Nagasawa |
Organization
Tokyo Medical and Dental University
Division name
Dysphagia rehabilitation, Graduate School of Medical and Dental Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8519, JAPAN
TEL
81-3-5803-5560
y.nagasawa.swal@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Nagasawa |
Organization
Tokyo Medical and Dental University
Division name
Dysphagia rehabilitation, Graduate School of Medical and Dental Sciences
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8519, JAPAN
TEL
81-3-5803-5560
Homepage URL
y.nagasawa.swal@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board, Tokyo Medical and Dental University, Dental Hospital
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8519, JAPAN
Tel
81-3-5803-5559
d-hyoka.adm@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
| 2023 | Year | 06 | Month | 29 | 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
| 2023 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058721
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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