UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the mechanism of therapeutic effect on tinnitus using fMRI
Title of the study (Brief title)	Study on tinnitus treatment effect by fMRI
Region	Japan

Condition
Condition	tinnitus
Classification by specialty	Oto-rhino-laryngology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We analyze therapeutic effect of tinnitus using functional MRI.
Basic objectives2	Others
Basic objectives -Others	we explore the mechanism and compare fMRI data between the patients with and witout tinnitus
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	we find out how the patinets with tinnitus improve.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	We asked patinets to wear hering aid for tinnitus patients and patients without tinnitus (both have hearing loss).
Interventions/Control_2	We examine hearing tests, tinnitus tests and fMRI analysis before and after hearing aid treatment for tinnitus patients and patients without tinnitus (both have hearing loss) and the treatment mechanism of sound therapy wearing hearing aids. Functional MRI photographs at the University of Tokyo Advanced Technology Center
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	60 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who can understand the contents of the research and obtain written informed consent There are geriatric hearing loss (there are high-frequency hearing loss on both sides), and further classified into two groups with or without senile tinnitus.
Key exclusion criteria	If one of the following applies, it is excluded. 1 Patient without physical fitness to withstand the field test in the planned research period 2 Other patients who have severe complications, mental / psychological conditions, etc. and are considered inappropriate for participation in this study.
Target sample size	40

Research contact person
Name of lead principal investigator	Sho Kanzaki
Organization	School of Medicine, Keio Univesity
Division name	Department of Otolaryngology
Address	35 Shinjuku Shinanomachi Tokyo Japan
TEL	0353633827
Email	skan@keio.jp

Public contact
Name of contact person	Sho Kanzaki
Organization	School of Medicine, Keio Univesity
Division name	Department of Otolaryngology
Address	35 Shinjuku Shinanomachi Tokyo Japan
TEL	0353633827
Homepage URL
Email	skan@keio.jp

Sponsor
Institute	Department of Otolaryngology, Keio Univesity
Institute
Department

Funding Source
Organization	Tateishi Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Research Center for Advanced Science and Technology The University of Tokyo, Tokyo Medical Center
Name of secondary funｄer(s)

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	2017 Year 01 Month 13 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 06 Day
Anticipated trial start date	2017 Year 02 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

Management information
Registered date	2017 Year 01 Month 13 Day
Last modified on	2017 Year 01 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029523