臨床研究等提出・公開システム

Scientific Title	Quantitative survey of disease burden and clinical practices for patients with tinnitus
Public Title	Survey of disease burden and clinical practices for patients with tinnitus

Contact for Scientific Queries	Name	Izawa Shigeru
	Affiliation	KYORIN Pharmaceutical Co., Ltd.
	Address	1-3-7, Otemachi, Chiyoda-ku, Tokyo, JAPAN
	Telephone	+81-3-6374-9708
	E-mail	shigeru.izawa@mb.kyorin-pharm.co.jp
Contact for Public Queries	Name	Yageta Yuichi
	Affiliation	KYORIN Pharmaceutical Co., Ltd
	Address	1-3-7, Otemachi, Chiyoda-ku, Tokyo, JAPAN
	Telephone	+81-3-6374-9708
	E-mail	yuuichi.yageta@mb.kyorin-pharm.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 18, 2024
Actual date of first enrollment		Dec. 19, 2024
Target sample size		1000
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1)Patients aged 18 years or older at the time of obtaining consent 2)Patients who fully understood the consent document and gave their own voluntary consent to participate in this study
	Exclusion Criteria	None
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Tinnitus
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Survey on respondents' background, disease burden, and medical treatment status - Background: gender, age group, severity of tinnitus (using the Tinnitus Handicap Inventory: THI), and status of medical institution, etc. - Disease burden, and medical treatment status: Work Productivity and Activity Impairment -General Health (WPAI-GH) Departments visited for tinnitus treatment and the number of medical institutions consulted Current of tinnitus explanation in medical institutions
Secondary Outcome(s)		Evaluate the disease burden and medical treatment status for each background.

Primary Sponsor	none

Source of Monetary Support / Secondary Sponsor	KYORIN pharmaceutical Co., Ltd.
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Research Ethics Committee
Address	1-3-7, Otemachi, Chiyoda-ku, Tokyo, Japan, Tokyo
Telephone	+81-3-6374-9708
E-Mail
Approval Status	Approval
Date of approval	Nov. 19, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history