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

Email

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


Email

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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014096


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name