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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040085
Receipt No. 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 2020/04/07

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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
Email 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
Email skan@a7.keio.jp

Sponsor
Institute Keio University
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, Shinjuku-ku, Tokyo
Tel 03-5363-3827
Email 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 Preinitiation
Date of protocol fixation
2020 Year 02 Month 19 Day
Date of IRB
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
2020 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045547

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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