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

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 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

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

Value
https://center6.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