UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study on the tinnitus and hyperacusis in patients with acute sensorineural hearing loss
Title of the study (Brief title)	Observational study on the tinnitus and hyperacusis in patients with acute sensorineural hearing loss
Region	Japan

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

Objectives
Narrative objectives1	observation of the appearance of tinnitus in patients with acute sensorineural hearing loss
Basic objectives2	Others
Basic objectives -Others	Diachronic evaluation of the symptoms
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	score of THI (tinnitus handicap inventory)
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	1) patients with acute sensorineural hearing loss within two weeks after onset 2) voluntary participants 3) age >= 20 years old 4) Peformance status = 0 or 1
Key exclusion criteria	1) Peripheral or central neurological diorders 2) Past history of the mental disease 3) Possiblity of the pregnancy 4) Possible participants whom it is judged to be inappropriate as a subjects
Target sample size	200

Research contact person
Name of lead principal investigator	Tetsuaki Kawase
Organization	Tohoku University Graduate School of Biomedical Engineering / Graduate School of Medicine
Division name	audiology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7303
Email	kawase@orl.med.tohoku.ac.jp

Public contact
Name of contact person	Tetsuaki Kawase
Organization	Tohoku University Graduate School of Biomedical Engineering / Graduate School of Medicine
Division name	audiology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7303
Homepage URL
Email	kawase@orl.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2015 Year 10 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 15 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	Termninated
Other related information	Study Design: cohort study Subjects: all that meet the selection criteria among the patients admitted to the hospital to participate in the present study. Measurement items: questionnaire and VAS (visual analogue scale) for the assessment of tinnitus and hyperacusis. hyperacusis.September 2018. Follow-up period: 1 year.

Management information
Registered date	2015 Year 10 Month 03 Day
Last modified on	2017 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022213