UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046229 |
|---|---|
| Receipt number | R000052759 |
| Scientific Title | Research on atmospheric pressure and headache |
| Date of disclosure of the study information | 2021/12/01 |
| Last modified on | 2023/06/03 06:48:40 |
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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
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
tsubasa.takizawa@z5.keio.jp
Sponsor or person
Institute
Department of Neurology, Keio University School of Medicine
Institute
Department
Personal name
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
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
60
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
| 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
| 2023 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052759
