UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028994 |
|---|---|
| Receipt number | R000033176 |
| Scientific Title | Confirmation test on the improving effects oral function by singing for long-term |
| Date of disclosure of the study information | 2017/09/04 |
| Last modified on | 2017/09/04 18:58:46 |
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Basic information
Public title
Confirmation test on the improving effects oral function by singing for long-term
Acronym
Confirmation test on the improving effects oral function by singing for long-term
Scientific Title
Confirmation test on the improving effects oral function by singing for long-term
Scientific Title:Acronym
Confirmation test on the improving effects oral function by singing for long-term
Region
| Japan |
Condition
Condition
Male and female aged 20 years over
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the improving effects of singing on karaoke in stress and oral functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
* VAS questionnaire
Key secondary outcomes
*Saliva test
*Swallowing function test
*Blood test
*Urinaly test
*POMS
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Singing on karaoke using DAM (Daiichikosyo Amusement Multimedia) four times a week (for one hour a day) for 4 weeks - Washout 4 weeks - No singing on karaoke for 4 weeks
Interventions/Control_2
No singing on karaoke for 4 weeks - Washout 4 weeks - Singing on karaoke using DAM (Daiichikosyo Amusement Multimedia) four times a week (for one hour a day) for 4 weeks
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)Male and female who aged 20 or older at the time of consent acquisition
(2)Subjects who can sing on karaoke singing about four times a week (1 hour per time)
(3)Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study
Key exclusion criteria
(1)Subjects who have previous and/or current medical history of serious heart, lung, kidney, digestive organ (including gastrectomy), blood, endocrine, or metabolic disease or current treatment for these diseases
(2)Subjects who regularly use health foods for modulating stress or immunity
(3)Subjects who are administered medicines related to respiratory, cardiac and vascular diseases
(4)Subjects who are difficult to visit the hospital
(5)Subjects who are depressed and unstable in mental condition or have ahigh psychogenic response
(6)Subjects who have been determined ineligible by principal investigator or sub-investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Tozuka |
Organization
DAIICHIKOSHO Co., Ltd.
Division name
ELDER BUSINESS DEPARTMENT
Zip code
Address
5-5-26 Kitashinagawa Shinagawa-ku, Tokyo, JAPAN
TEL
03-6381-3015
kami@dkkaroke.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhisa Sakano |
Organization
CPCC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
PREMEDICO Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
DAIICHIKOSHO Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 09 | Month | 04 | 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
| 2014 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 24 | 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
| 2017 | Year | 09 | Month | 04 | Day |
Last modified on
| 2017 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033176
