UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020080 |
|---|---|
| Receipt number | R000023191 |
| Scientific Title | Research on test battery to evaluate subjective and objective hearing of hearing aid users |
| Date of disclosure of the study information | 2016/01/04 |
| Last modified on | 2017/12/06 19:46:21 |
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Basic information
Public title
Research on test battery to evaluate subjective and objective hearing of hearing aid users
Acronym
Test battery for hearing aid users
Scientific Title
Research on test battery to evaluate subjective and objective hearing of hearing aid users
Scientific Title:Acronym
Test battery for hearing aid users
Region
| Japan |
Condition
Condition
hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Perform subjective and objective hearing test on hearing aid users and to determine the appropriate test battery to evaluate hearing aids.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CI2004 Japanese speech recognition test score.
Key secondary outcomes
Pure tone audiogram, monosyllable recognition test under hearing aid, Speech, Spatial and Qualities of Hearing scale (SSQ) results.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Evaluate Japanese speech recognition ability of hearing aid users using a test (CI2004) designed for cochlear implant users.
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. Able to understand and decide.
2. Native Japanese speaker.
3. Bilateral hearing loss with >= 45dB hearing threshold in 3-frequency average in both ears.
4. Maximum speech recognition >= 50% at least in one ear.
5. Speech recognition at 50dB <= 50% at least in one ear.
6. Provide written informed consent.
Key exclusion criteria
1. Poor overall health that makes 3 sets of extensive hearing tests invasive.
2. Hearing loss due to bilateral acoustic neuroma.
3. Hearing loss due to intracranial surgery.
4. Hearing loss due to cranial trauma.
5. Scheduled chemotherapy that includes ototoxic anticancer drugs during the research period.
6. Other medical condition that a doctor decides inappropriate to include in the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Torahiko Nakashima |
Organization
Kyushu University Hospital
Division name
Department of Otorhinolaryngology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
81-92-642-5668
nakatora@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomu Matsumoto |
Organization
Kyushu University Hospital
Division name
Department of Otorhinolaryngology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
81-92-642-5668
Homepage URL
matunozo@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Oticon Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Oticon Japan
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
| 2016 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/29157624
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 | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 05 | Day |
Last modified on
| 2017 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023191
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
