UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040085 |
|---|---|
| Receipt number | R000045547 |
| Scientific Title | analysis on the change of barometric pressure and physical sensation autonomic nerve function |
| Date of disclosure of the study information | 2020/04/07 |
| Last modified on | 2022/04/18 12:26:03 |
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Basic information
Public title
analysis on the change of barometric pressure and physical sensation autonomic nerve function
Acronym
barometric pressure and autonomic nerve function
Scientific Title
analysis on the change of barometric pressure and physical sensation autonomic nerve function
Scientific Title:Acronym
barometric pressure and autonomic nerve function
Region
| Japan |
Condition
Condition
vertigo/ tinnitus/ headache
Classification by specialty
| Neurology | Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate vital data such as changes in body sensation and autonomic nervous response of healthy subjects due to weather changes.
Basic objectives2
Others
Basic objectives -Others
Some people complain of exacerbation of symptoms such as headache and vertigo due to weather changes, particularly barometric pressure. In order to compare with those who have symptoms, the changes in the body reaction of healthy subjects during weather changes are examined.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
autonomic nervous activity
Key secondary outcomes
Heart rate
Respiratory rate
Body temperature
Sensory changes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Measurement of barometric pressure change and autonomic nerveous system during get on the elevator.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy adults without headache or vertigo
Key exclusion criteria
Patients who do not cooperate recording diary
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Kanzaki |
Organization
Keio University School of Medicine
Division name
Department of Otolaryngology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3827
skan@a7.keio.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kanzaki |
Organization
Keio University School of Medicine
Division name
Department of Otolaryngology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3827
Homepage URL
skan@a7.keio.jp
Sponsor or person
Institute
Keio University
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, Shinjuku-ku, Tokyo
Tel
03-5363-3827
skan@a7.keio.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
| 2020 | Year | 04 | Month | 07 | 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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 07 | 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
| 2020 | Year | 04 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045547
