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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034943
Receipt No. 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

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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
Email 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
Email emoto@tokushima-u.ac.jp

Sponsor
Institute Tokushima university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039841

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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