UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012335 |
|---|---|
| Receipt number | R000014423 |
| Scientific Title | Effects of head extention and mouth opening on swallowing ability in the supine position |
| Date of disclosure of the study information | 2013/11/18 |
| Last modified on | 2018/08/29 11:33:48 |
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Basic information
Public title
Effects of head extention and mouth opening on swallowing ability in the supine position
Acronym
Effects of head extention and mouth opening on swallowing ability in the supine position
Scientific Title
Effects of head extention and mouth opening on swallowing ability in the supine position
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hanamoto |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthsiology
Zip code
Address
1-8, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2972
hanamoto@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Hanamoto |
Organization
Osaka University Graduate School of Dentistry
Division name
Department of Dental Anesthsiology
Zip code
Address
1-8, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-2972
Homepage URL
hanamoto@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
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)
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
| 2013 | Year | 11 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 07 | Month | 28 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014423
