UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Confirmation test on the improving effects oral function by singing for long-term
Title of the study (Brief title)	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	Keisuke Tozuka
Organization	DAIICHIKOSHO Co., Ltd.
Division name	ELDER BUSINESS DEPARTMENT
Address	5-5-26 Kitashinagawa Shinagawa-ku, Tokyo, JAPAN
TEL	03-6381-3015
Email	kami@dkkaroke.co.jp

Public contact
Name of contact person	Katsuhisa Sakano
Organization	CPCC Co., Ltd.
Division name	Clinical Research Planning Department
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	PREMEDICO Co., Ltd.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033176