UMIN-CTR Clinical Trial

Basic information
Public title	analisys on associations between the of weather and change of vertigo, dizziness, hearing loss and tinnitus.
Acronym	weather and change of vertigo, dizziness, hearing loss and tinnitus
Scientific Title	analisys on associations between the status of weather and change of vertigo, dizziness, hearing loss and tinnitus.
Scientific Title:Acronym	weather and change of vertigo, dizziness, hearing loss and tinnitus
Region	Japan

Condition
Condition	vertigo/ hearing loss/ tinnitus
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigations on the relationship between vertigo, hearing loss, tinnitus and weather conditions.
Basic objectives2	Others
Basic objectives -Others	The purpose is to analyze whether there are individual differences, what weather conditions have worsen the symptoms.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in symptoms of vertigo, hearing loss, tinnitus due to weather change.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have any or all symptoms of vertigo, hearing loss, and tinnitus, who can cooperate with the description and who can agree to participate in the study every day.
Key exclusion criteria	None
Target sample size	50

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	0353633827
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	0353633827
Homepage URL
Email	skan@a7.keio.jp

Sponsor
Institute	Department of Otolaryngology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Keio University School of Medicine
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	0353633827
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 03 Month 25 Day
Date of IRB	2020 Year 03 Month 25 Day
Anticipated trial start date	2020 Year 04 Month 10 Day
Last follow-up date	2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Changes in symptoms related to vertigo, hearing loss, and tinnitus, and the weather conditions when symptoms occur(or the date and time to investigate the weather conditions), medication status, etc.

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=R000045548

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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