UMIN-CTR Clinical Trial

Basic information
Public title	Effects of repeated aural stimulation on swallowing function and incidence of aspiration pneumonia in patients with dysphagia
Acronym	Effects of repeated aural stimulation on swallowing function and incidence of aspiration pneumonia in patients with dysphagia
Scientific Title	Effects of repeated aural stimulation on swallowing function and incidence of aspiration pneumonia in patients with dysphagia
Scientific Title:Acronym	Effects of repeated aural stimulation on swallowing function and incidence of aspiration pneumonia in patients with dysphagia
Region	Japan

Condition
Condition	dysphagia
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the present study, an attempt is made to examine effects of repeated aural stimulation on swallowing function and the incidence of aspiration pneumonia in patients with dysphagia. Their swallowing is recorded by transnasal videoendoscopy and evaluated with Hyodo and SMRC scaling method. The incidence of aspiration pneumonia during aural stimulation is compared with that before the study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Swallowing function Incidence of aspitaion pneumonia
Key secondary outcomes

Base
Study type	Interventional

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Repeated aural stimulation
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with dysphagia who have been suffered from aspiration
Key exclusion criteria	Patients who was excluded by investigators Patients who cannot follow an instruction of swallowing
Target sample size	70

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Noriaki Takeda
Organization	University of Tokushima School of Medicine
Division name	Department of Otolaryngology
Zip code
Address	3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL	088-633-7169
Email	takeda@tokushima-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Noriaki Takeda
Organization	University of Tokushima School of Medicine
Division name	Department of Otolaryngology
Zip code
Address	3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL	088-633-7169
Homepage URL
Email	takeda@tokushima-u.ac.jp

Sponsor
Institute	University of Tokushima School of Medicine
Institute
Department

Funding Source
Organization	self-funding
Organization
Division
Category of Funding Organization	Self funding
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	徳島大学病院（徳島県）、三野田中病院（徳島県）、香川大学病院（香川県）、鳴門山上病院（徳島県）、美馬リハビリテーション病院・老健施設（徳島県）、木下病院・平成苑（徳島県）、松村病院（徳島県）、折野胃腸科内科・老健施設（徳島県）、徳島県立海部病院（徳島県）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 01 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	Completed
Date of protocol fixation	2013 Year 10 Month 15 Day
Date of IRB	2013 Year 11 Month 29 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2019 Year 03 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 16 Day
Last modified on	2019 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014096