UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of an effectiveness of swallowing dynamics evaluation on swallowing sound for dysphagia patients
Title of the study (Brief title)	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	Yoshitaka Suzuki
Organization	Tokushima University Hospital
Division name	Dentistry
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	Takahiro Emoto
Organization	Tokushima University
Division name	Graduate school of technology, induatrial and social sciences
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 11 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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