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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030519
Receipt No. R000034843
Scientific Title Study about a breathing timing and the deglutition timing in the respirator wearing patients
Date of disclosure of the study information 2017/12/22
Last modified on 2017/12/22

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Basic information
Public title Study about a breathing timing and the deglutition timing in the respirator wearing patients
Acronym Study of the timing of breathing and the deglutition
Scientific Title Study about a breathing timing and the deglutition timing in the respirator wearing patients
Scientific Title:Acronym Study of the timing of breathing and the deglutition
Region
Japan

Condition
Condition Myopathy
Neurologic disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine whether you are associated with the ventilatory pattern of the use of respirator patients in a deglutition timing.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ventilation timing of the respirator.
Hearing of the deglutition sound.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Being neurologic disease and myopathy.
Key exclusion criteria pneumonia.
The patients who cannot do mutual understanding.
The patients who were judged to be inadequate.s who were judged to be inadequate.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomotaka Ueda
Organization Nishikyusyu University
Division name Faculty of Rehabilitation Sciences
Zip code
Address 4490-9 Ozaki Kanzaki-city, Saga, JP
TEL 0952-52-4191
Email tmtk0612-nisikyu@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomotaka Ueda
Organization Nishikyusyu University
Division name Faculty of Rehabilitation Sciences
Zip code
Address 4490-9 Ozaki Kanzaki-city, Saga, JP
TEL 0952-52-4191
Homepage URL
Email tmtk0612-nisikyu@yahoo.co.jp

Sponsor
Institute Nishikyusyu University
Institute
Department

Funding Source
Organization Nishikyusyu University
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 長崎川棚医療センター(長崎県)仙台徳洲会病院(宮城県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Ventilation timing of the respirator.
Hearing of the deglutition sound.

Management information
Registered date
2017 Year 12 Month 22 Day
Last modified on
2017 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034843

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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