UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020191
Receipt number R000023316
Scientific Title Examination of the microphone attaching position which is most suitable for the swallowing sound recording
Date of disclosure of the study information 2015/12/15
Last modified on 2015/12/17 18:23:26

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Basic information

Public title

Examination of the microphone attaching position which is most suitable for the swallowing sound recording

Acronym

Examination of the microphone attaching position which is most suitable for the swallowing sound recording

Scientific Title

Examination of the microphone attaching position which is most suitable for the swallowing sound recording

Scientific Title:Acronym

Examination of the microphone attaching position which is most suitable for the swallowing sound recording

Region

Japan


Condition

Condition

Dysphagia

Classification by specialty

Dental medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To record the swallowing sound using plural small microphones from various parts of the neck, and examine the microphone attaching part that is most suitable for the swallowing sound recording.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Volume of swallowing sound

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

Prevention

Type of intervention

Other

Interventions/Control_1

Swallowing the following food at the time of swallowing sound recording.
1)tea 1cc, tea 5cc
2)yogurt 1cc, yogurt 5cc

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

35 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adult who without oral function abnormality

Key exclusion criteria

There is awareness of dysphagia.

Target sample size

14


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shogo Minagi

Organization

Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University

Division name

Department of Occlusal and Oral Functional Rehabilitation

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

TEL

086-235-6687

Email

minagi@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoto Maeda

Organization

Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama University

Division name

Department of Occlusal and Oral Functional Rehabilitation

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

TEL

086-235-6687

Homepage URL


Email

naoto-m-10@t.okadai.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name



Funding Source

Organization

Okayama University

Organization

Division

Category of Funding 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

2015 Year 12 Month 15 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

No longer recruiting

Date of protocol fixation

2015 Year 07 Month 28 Day

Date of IRB


Anticipated trial start date

2015 Year 12 Month 15 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

2015 Year 12 Month 14 Day

Last modified on

2015 Year 12 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023316


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name