UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021608 |
|---|---|
| Receipt number | 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 | 2021/03/29 16:21:24 |
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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 | Kayoko |
| Middle name | |
| Last name | Kabaya |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Otolaryngology - Head and Neck Surgery
Zip code
4678602
Address
1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL
0528538256
kabaya@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kayoko |
| Middle name | |
| Last name | Kabaya |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Otolaryngology - Head and Neck Surgery
Zip code
4678602
Address
1 Kawasumi Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL
0528538256
Homepage URL
kabaya@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Department of Otolaryngology - Head and Neck Surgery, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
Clinical Research Management center, Nagoya City University Hospital
Address
1 Kawasumi Mizuho-cho Mizuho-ku
Tel
0528587215
clinical_research@med.nagoya-cu.ac.jp
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 30 | Day |
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
| 2021 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024923
