UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022425 |
|---|---|
| Receipt number | R000025837 |
| Scientific Title | The change of the brain activity with unilateral hearing loss patients in noisy environment |
| Date of disclosure of the study information | 2016/05/24 |
| Last modified on | 2023/11/28 18:33:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The change of the brain activity with unilateral hearing loss patients in noisy environment
Acronym
The change of the brain activity with unilateral hearing loss patients
Scientific Title
The change of the brain activity with unilateral hearing loss patients in noisy environment
Scientific Title:Acronym
The change of the brain activity with unilateral hearing loss patients
Region
| Japan |
Condition
Condition
Sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We want to analyze relation between chief complaint of unilateral hearing loss patients and their brain activity.
Basic objectives2
Others
Basic objectives -Others
Analysis of the brain activity with fMRI
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difficulty of hearing in a nosy environment with unilateral hearing loss patients
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
once fMRI
for one day
Interventions/Control_2
once fMRI
for one day
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy-side is within 25dB
unilateral hearing loss -side is more than 90dB
Key exclusion criteria
the patients with brain operations
the congenital hearing loss patients
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Tsutsumi |
Organization
Tokyo Medical and Dental university
Division name
Otorhinolaryngology
Zip code
113-8510
Address
1-5-45 Yushima Bunnkyo- ku
TEL
5803-5303
kyamoto@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Katsura |
| Middle name | |
| Last name | Yamamoto |
Organization
Tokyo Medical and Dental university
Division name
Otorhinolaryngology
Zip code
113-8510
Address
1-5-45 Yushima Bunnkyo- ku
TEL
5803-5308
Homepage URL
kyamoto@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental university
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental university
Address
1-5-45 Yushima Bunnkyo- ku
Tel
0358035308
kyamoto@tmd.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
In comparisons between individuals with hearing-loss patients and healthy volunteers, it was observed that hearing-loss patients exhibited greater brain activity in the frontal regions.
Furthermore, in patients with hearing loss in both ears, it was confirmed that the increase and decrease of neural activity varied depending on the region of the brain."
Results date posted
| 2023 | Year | 11 | Month | 28 | Day |
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 | 05 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 26 | Day |
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
| 2023 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025837
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
