UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034943 |
|---|---|
| Receipt number | R000039841 |
| Scientific Title | Clinical study of an effectiveness of swallowing dynamics evaluation on swallowing sound for dysphagia patients |
| Date of disclosure of the study information | 2018/11/19 |
| Last modified on | 2018/11/19 17:42:09 |
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Basic information
Public title
Clinical study of an effectiveness of swallowing dynamics evaluation on swallowing sound for dysphagia patients
Acronym
Swallowing dynamics evaluation on swallowing sound for dysphagia patients
Scientific Title
Clinical study of an effectiveness of swallowing dynamics evaluation on swallowing sound for dysphagia patients
Scientific Title:Acronym
Swallowing dynamics evaluation on swallowing sound for dysphagia patients
Region
| Japan |
Condition
Condition
Dysphagia
Classification by specialty
| Oto-rhino-laryngology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investgate an effectiveness of swallowing dynamics evaluation on swallowing sound
by analysing the sound based on Video Fluoroscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Swallowing sound
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Recording swallowing sound of dysphagia patients by a microphone
Interventions/Control_2
Recording swallowing sound of non-dysphagia patients by a microphone
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
Inpatients or outpatients who need VF to diagnose dysphagia
Key exclusion criteria
Patients who do not obtain consent, Patients who do not need or can not undergo VF, Patient with tracheotomy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Suzuki |
Organization
Tokushima University Hospital
Division name
Dentistry
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima, Tokushima, JAPAN
TEL
088-633-7350
yosuzuki@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Emoto |
Organization
Tokushima University
Division name
Graduate school of technology, induatrial and social sciences
Zip code
Address
2-1 Minami-josanjima-cho, Tokushima, Tokushima, JAPAN
TEL
088-656-7304
Homepage URL
emoto@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima university
Institute
Department
Personal name
Funding Source
Organization
Other (we do not want to disclose.)
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
| 2018 | Year | 11 | Month | 19 | 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
| 2018 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 19 | 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
| 2018 | Year | 11 | Month | 19 | Day |
Last modified on
| 2018 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039841
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
