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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021608
Receipt No. R000024923
Scientific Title The efficacy of sound therapy by the tone and/or noise for tinnitus patients with normal hearing
Date of disclosure of the study information 2016/03/25
Last modified on 2017/09/08

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Basic information
Public title The efficacy of sound therapy by the tone and/or noise for tinnitus patients with normal hearing
Acronym The efficacy of sound therapy by the tone and/or noise for tinnitus patients with normal hearing
Scientific Title The efficacy of sound therapy by the tone and/or noise for tinnitus patients with normal hearing
Scientific Title:Acronym The efficacy of sound therapy by the tone and/or noise for tinnitus patients with normal hearing
Region
Japan

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

Objectives
Narrative objectives1 To examine the efficacy of sound therapy by the tone and/or noise for tinnitus patients with normal hearing.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change of Tinnitus Handicap Inventory after 1, 2, and 3 month.
Key secondary outcomes Change of visual analogue scale (loudness, duration, intention) after 1, 2, and 3 month.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Use Zen tone
3 months
Interventions/Control_2 Use noise generator
3 months
Interventions/Control_3 Use Zen tone and noise generator
3 months
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. with tinnitus
2.no hearing loss
Key exclusion criteria 1) the patient for whom it's difficult to understand and continue
2) the patient with serious mental diseases
3) other reasons inadequate for study participation
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kayoko Kabaya
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Otolaryngology - Head and Neck Surgery
Zip code
Address 1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL 052-853-8256
Email kabaya@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kayoko Kabaya
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Otolaryngology - Head and Neck Surgery
Zip code
Address 1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL 052-853-8256
Homepage URL
Email kabaya@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Otolaryngology - Head and Neck Surgery, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Department of Otolaryngology - Head and Neck Surgery, Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 名古屋市立大学病院(愛知県)春日市市民病院(愛知県)、豊橋市民病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 25 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 Open public recruiting
Date of protocol fixation
2016 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 25 Day
Last modified on
2017 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024923

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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