UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035310 |
|---|---|
| Receipt number | 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 | 2021/12/27 17:03:44 |
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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
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
kawayama_tomotaka@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume Univeristy
Institute
Department
Personal name
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
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
| 2023 | 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
| 2021 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.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 |
