UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045547