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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022413
Receipt No. R000025830
Scientific Title Evaluation of effect of sound stimulation on physiological functions
Date of disclosure of the study information 2016/07/01
Last modified on 2017/11/24

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Basic information
Public title Evaluation of effect of sound stimulation
on physiological functions
Acronym Evaluation of sound stimulation
Scientific Title Evaluation of effect of sound stimulation
on physiological functions
Scientific Title:Acronym Evaluation of sound stimulation
Region
Japan

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

Objectives
Narrative objectives1 This study aims at evaluating frequency- depedent effect of sounds on physiological functions in humans.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Exams of hearing and vestibular functions before and after sound exposure.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 A sound stimulation at less than 95 dB is performed for 5-10 min.
Interventions/Control_2 no exposure group
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) Vertigo: Patients with subjective symptoms or with impairments of VOR or MRI of inner ears.
2) Tinnitus: Patients with subjective symptoms or with impairments of Tinnitus Handicap Inventory (THI; Newman CW, et al. Arch Otolaryngol Head Neck Surg, 122: 143-148,1996).
3) Healthy subjects: Subjects without impairments of the above.
Key exclusion criteria Subjects below 20 years old are excluded. In the case of subjects even above 20 years old, subjects who do not have a sound judgement and consciousness and who need to be considered for diseases are also excluded. In addition, subjects who are not applicable to medical instruments used in this study are excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Kato
Organization Nagoya University Graduate School of Medicine
Division name Occupational and Environmental Health
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2124
Email katomasa@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobutaka Ohgami
Organization Nagoya University Graduate School of Medicine
Division name Occupational and Environmental Health
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2124
Homepage URL
Email meieisei@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 01 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 Enrolling by invitation
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 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 05 Month 23 Day
Last modified on
2017 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025830

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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