UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012055 |
|---|---|
| Receipt number | R000014096 |
| Scientific Title | Effects of repeated aural stimulation on swallowing function and incidence of aspiration pneumonia in patients with dysphagia |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2019/03/14 20:24:54 |
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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
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
takeda@tokushima-u.ac.jp
Public contact
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
takeda@tokushima-u.ac.jp
Sponsor or person
Institute
University of Tokushima School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014096
