UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Objective fatigue and stress evaluation of dizziness, acute hearing loss,and tinnitus
Title of the study (Brief title)	Objective fatigue and stress evaluation of dizziness, acute hearing loss,and tinnitus
Region	Japan

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

Objectives
Narrative objectives1	Objective fatigue and stress evaluation of dizziness, acute hearing loss, and tinnitus with saliva and blood test
Basic objectives2	Others
Basic objectives -Others	Clinical characteristics of dizziness, acute hearing loss, and tinnitus
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessments of clinical dizziness, acute hearing loss, and tinnitus symptoms, blood and saliva samples
Key secondary outcomes

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	whether stress marker present of saliva and blood test or not. Intervention period is only one day at the time of the initial examination.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with dizziness or acute hearing loss or tinnitus
Key exclusion criteria	dementia Terminal cancer Acute infection Severe physical illness
Target sample size	600

Research contact person
Name of lead principal investigator	Izumi koizuka
Organization	St. Marianna Uniersity school of medicine
Division name	Department of otorhinolaryngology
Address	Sugao 2-16-1, Miyamae-ku, Kawasaki
TEL	044-977-8111
Email	koizuka@marianna-u.ac.jp

Public contact
Name of contact person	Akihiro Ohara
Organization	St. Marianna Uniersity school of medicine
Division name	Department of otorhinolaryngology
Address	Sugao 2-16-1, Miyamae-ku, Kawasaki
TEL	044-977-8111
Homepage URL
Email	a2ohara@marianna-u.ac.jp

Sponsor
Institute	St. Marianna Uniersity school of medicine, department of otorhinolaryngology
Institute
Department

Funding Source
Organization	The Jikei University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	The Jikei University School of Medicine
Name of secondary funｄer(s)	Virus Ikagaku Kenkyusho Inc.

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	聖マリアンナ医科大学病院（神奈川県） 川崎市立多摩病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 02 Month 08 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	none

Management information
Registered date	2016 Year 02 Month 13 Day
Last modified on	2018 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024246