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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035310
Receipt No. R000040235
Scientific Title Sex differences of brain signals and neuron networks on effort breath by functional magnetic resonance imaging techniques and effort levels of respiratory muscles in artificial effort breathing
Date of disclosure of the study information 2018/12/25
Last modified on 2019/07/11

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Basic information
Public title Sex differences of brain signals and neuron networks on effort breath by functional magnetic resonance imaging techniques and effort levels of respiratory muscles in artificial effort breathing
Acronym Sex differences of brain signals on effort breath
Scientific Title Sex differences of brain signals and neuron networks on effort breath by functional magnetic resonance imaging techniques and effort levels of respiratory muscles in artificial effort breathing
Scientific Title:Acronym Sex differences of brain signals on effort breath
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Medicine in general Pneumology Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to investigate sex differences of brain signals and neuron on effort breath networks by functional magnetic resonance imaging techniques
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary endpoint is to prove sex differences of brain signals and neuron networks on effort breath by functional magnetic resonance imaging techniques
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Effort breath
Interventions/Control_2 normal breath
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
50 years-old >=
Gender Male and Female
Key inclusion criteria healthy
Key exclusion criteria Any histories of any diseases
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomotaka
Middle name
Last name Kawayama
Organization Kurume University
Division name Department of medicine
Zip code 830-0011
Address 67 Asahimachi, Kurume
TEL 0942-31-7560
Email kawayama_tomotaka@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name Tomotaka
Middle name
Last name Kawayama
Organization Kurume University
Division name Department of medicine
Zip code 830-0011
Address 67 Asahimachi, Kurume
TEL 0942-31-7560
Homepage URL
Email kawayama_tomotaka@med.kurume-u.ac.jp

Sponsor
Institute Kurume Univeristy
Institute
Department

Funding Source
Organization KAKEN
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kurume University
Address 67 Asahimachi, Kurume
Tel 0942-35-3311
Email sangakuml@kurume-u.ac.jp

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
2018 Year 12 Month 25 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 30
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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 17 Day
Date of IRB
2018 Year 12 Month 20 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 19 Day
Last modified on
2019 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040235

Research Plan
Registered date File name
2019/07/11 2_fMRI&呼吸呼吸困難と性差_研究計画書_11162018(11.27).docx

Research case data specifications
Registered date File name
2019/07/11 4_fMRI呼吸呼吸困難と性差_ケースカード_01062019.docx

Research case data
Registered date File name


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