UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006807 |
|---|---|
| Receipt number | R000008058 |
| Scientific Title | Evaluation of improvement in speech recognition by electro-acoustic stimulation in high-frequency deafness |
| Date of disclosure of the study information | 2011/12/01 |
| Last modified on | 2015/05/07 20:26:51 |
* 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
Evaluation of improvement in speech recognition by electro-acoustic stimulation in high-frequency deafness
Acronym
Improvement in speech recognition by electro-acoustic stimulation
Scientific Title
Evaluation of improvement in speech recognition by electro-acoustic stimulation in high-frequency deafness
Scientific Title:Acronym
Improvement in speech recognition by electro-acoustic stimulation
Region
| Japan |
Condition
Condition
High-frequency deafness
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm safety of electro-acoustic stimulation device and evaluate improvement of speech recognition of Japanese language by electro-acoustic stimulation in high-frequency deafness
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To observe whether side effects such as postoperative infection remain prevented or not, and to evaluate auditory and vestubular functions after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients with high-freqency deafness who fulfill the trial criteria will be inplanted with electro-acoustic stumulation device after informed consent
Interventions/Control_2
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)Patients whose both ears fulfils following limitations
Threshold at 125, 250 and 500Hz >= 65dB
Threshold at 2000Hz >= 80dB
Threshold at 4000 and 8000Hz >= 85dB
NB:a single exception among the seven frequencies is accepted
2)Speech descrimination rate with hearing aid in silent booth < 60%
3)age >= 20
4)informed consent
5)patient motivated for hearing improvement
Key exclusion criteria
Patients with metal device in the body
Stenosis of intracochlear space for electrodes
Active infection of middle ear
Severe mental dysfunction
Dysfunction in central auditory pathway
Severe diease unsuitable for general anesthesia
Patients judged unsuitable by the practioner of the trial
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yamasoba |
Organization
University of Tokyo Hospital
Division name
Department of Otolaryngology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
tyamasoba-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yamasoba |
Organization
University of Tokyo Hospital
Division name
Department of Otolaryngology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
tyamasoba-tky@umin.ac.jp
Sponsor or person
Institute
Tatsuya Yamasoba
Institute
Department
Personal name
Funding Source
Organization
Research grant by the Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 12 | 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
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 30 | Day |
Last modified on
| 2015 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008058
