UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of head extention and mouth opening on swallowing ability in the supine position
Title of the study (Brief title)	Effects of head extention and mouth opening on swallowing ability in the supine position
Region	Japan

Condition
Condition	healthy adult volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate whether head position and mouth opening affect the swallowing ability.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The outcome variables aere the volume of remaining water, duration of swallowing and peak amplitude of SH EMG.
Key secondary outcomes

Base
Study type

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	water swallowing test
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	healthy adult
Key exclusion criteria	history of swallowing problems
Target sample size	15

Research contact person
Name of lead principal investigator	Hiroshi Hanamoto
Organization	Osaka University Graduate School of Dentistry
Division name	Department of Dental Anesthsiology
Address	1-8, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-2972
Email	hanamoto@dent.osaka-u.ac.jp

Public contact
Name of contact person	Hitoshi Hanamoto
Organization	Osaka University Graduate School of Dentistry
Division name	Department of Dental Anesthsiology
Address	1-8, Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-2972
Homepage URL
Email	hanamoto@dent.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research from the ministry of Education, Science and Culture of Japan (No. 23792334)
Organization
Division
Category of Funding 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	2013 Year 11 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 28 Day
Anticipated trial start date	2013 Year 07 Month 28 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 18 Day
Last modified on	2018 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014423