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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046229
Receipt No. R000052759
Scientific Title Research on atmospheric pressure and headache
Date of disclosure of the study information 2021/12/01
Last modified on 2021/12/01

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Basic information
Public title Research on atmospheric pressure and headache
Acronym Research on atmospheric pressure and headache
Scientific Title Research on atmospheric pressure and headache
Scientific Title:Acronym Research on atmospheric pressure and headache
Region
Japan

Condition
Condition Migraine
Classification by specialty
Medicine in general Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects of changes in atmospheric pressure on migraine etc.
Basic objectives2 Others
Basic objectives -Others Assessing the clinical characteristics, autonomic function, and psychological testing of migraine patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Headache after entering the machine which can change the atmospheric pressure etc.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Trial subject will enter a machine that can change barometric pressure
Change in barometric pressure
Interventions/Control_2 Trial subject will enter a machine that can change barometric pressure
No change in barometric pressure (control)
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
70 years-old >
Gender Male and Female
Key inclusion criteria Migraine patients who have given consent to enter the machine which can change barometric pressure, and answer the questionnaire.
Key exclusion criteria Patients with difficulty in ear extraction,
Patients with claustrophobia,
Patients who were judged to be unsuitable for this study, etc.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Tsubasa
Middle name
Last name Takizawa
Organization Keio University School of Medicine
Division name Department of Neurology
Zip code 160-8582
Address 35 Shinanomachi, Shijuku-ku, Tokyo
TEL 0353633788
Email tsubasa.takizawa@z5.keio.jp

Public contact
Name of contact person
1st name Tsubasa
Middle name
Last name Takizawa
Organization Keio University School of Medicine
Division name Department of Neurology
Zip code 160-8582
Address 35 Shinanomachi, Shijuku-ku, Tokyo
TEL 03-5363-3788
Homepage URL
Email tsubasa.takizawa@z5.keio.jp

Sponsor
Institute Department of Neurology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Keio University School of Medicine
Address 35 Shinanomachi, Shijuku-ku, Tokyo
Tel 0333531211
Email med-rinri-jimu@adst.keio.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
2021 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 Open public recruiting
Date of protocol fixation
2021 Year 11 Month 06 Day
Date of IRB
2021 Year 11 Month 15 Day
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2026 Year 03 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
2021 Year 11 Month 30 Day
Last modified on
2021 Year 12 Month 01 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052759

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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