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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name