UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005035 |
|---|---|
| Receipt number | R000005988 |
| Scientific Title | A study about the therapy against age-related hearing loss for individual based on QOL and oxidant stress . ~An inquest of the prognostic factor for communicative environment with hearing aids~ |
| Date of disclosure of the study information | 2011/02/05 |
| Last modified on | 2013/08/05 14:51:05 |
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Basic information
Public title
A study about the therapy against age-related hearing loss for individual based on QOL and oxidant stress . ~An inquest of the prognostic factor for communicative environment with hearing aids~
Acronym
An inquest of the prognostic factor for communicative environment with hearing aids
Scientific Title
A study about the therapy against age-related hearing loss for individual based on QOL and oxidant stress . ~An inquest of the prognostic factor for communicative environment with hearing aids~
Scientific Title:Acronym
An inquest of the prognostic factor for communicative environment with hearing aids
Region
| Japan |
Condition
Condition
age-related hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We figure out the communicative environment of age-related hearing loss in Japan, and clarify the prognostic factor for communicative environment with hearing aids.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Handicap Inventory for the Elderly, SF-36, and questionnaire for hearing.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with age-related hearing loss over 60 year sold, who are eligible for hearing aids
Key exclusion criteria
The patients with otitis media or unilateral deafness, or who cannot fill out the questionnaires
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Fujii |
Organization
National Hospital Organization Tokyo Medical Center
Division name
National Institute of Sensory Organs
Zip code
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shujiro Minami |
Organization
National Hospital Organization Tokyo Medical Center
Division name
Department of Otolaryngology
Zip code
Address
2-5-1 Higashigaoka, Meguro, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
National Hospital Organization Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Network Grant
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
名古屋医療センター（愛知県）、岡山医療センター（岡山県）、呉医療センター（広島県）、神戸医療センター（兵庫県）、嬉野医療センター（佐賀県）、仙台医療センター（宮城県）、栃木病院（栃木県）、慶應義塾大学医学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 05 | 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
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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
At first the patients fill out the questionnaires, and then are fitted with the hearing aids. 3 month, 1 and 2 year after, they fill out he questionnaires again.
Management information
Registered date
| 2011 | Year | 02 | Month | 05 | Day |
Last modified on
| 2013 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005988
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
