UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025213 |
|---|---|
| Receipt number | R000029001 |
| Scientific Title | analysis of cognitive function and symptom effected by hearing device fitting in aged patients with hearing impairment |
| Date of disclosure of the study information | 2016/12/20 |
| Last modified on | 2023/08/09 15:38:32 |
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Basic information
Public title
analysis of cognitive function and symptom effected by hearing device fitting in aged patients with hearing impairment
Acronym
hearing device and cognitive impairment
Scientific Title
analysis of cognitive function and symptom effected by hearing device fitting in aged patients with hearing impairment
Scientific Title:Acronym
hearing device and cognitive impairment
Region
| Japan |
Condition
Condition
mild cognitive impairment and dementia
age-related hearing loss
Classification by specialty
| Neurology | Geriatrics | Oto-rhino-laryngology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elderly people are often suffering from age-related hearing loss and dementia. In the present study, we are planning to establish a new visually oriented test battery to precisely evaluate cognitive function even in patients with hearing loss. In addition, we elucidate which aspects of cognitive function are ameliorated by hearing device fitting in aged patients with both dementia and hearing loss. Through these investigation, we aim to find out what type of patients with dementia are recommended to use hearing aid. Results of the present study will contribute to further large clinical trials assessing correlation between cognitive function and hearing impairment.ls to be conducted in the near future.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To determine which aspects of cognitive function are ameliorated by hearing device fitting in aged patients with cognitive impairment and age-related hearing loss
Key secondary outcomes
Development of a new visually oriented test battery to precisely evaluate cognitive function even in patients with hearing loss
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) those who are diagnosed as having moderate to profound hearing loss and indicated for hearing device fitting
2) those who have not used hearing device in past one year or quit using hearing device before three months consequently
3) those who have no apparent ear disease such as acute otitis media or otitis media with effusion in the better hearing ear
Key exclusion criteria
1) those with past history of neurological or psychiatric diseases, such as alcohol abuse, drug abuse, depression, paranoid disorder, metabolism disorder, endocrine disease, normal pressure hydrocephalus, subdural hematoma, which could affect cognitive function
2) those who are not able to perform hearing tests
3) those who change main medication for cognitive function in research period
4) those who show deterioration of hearing level with more than 20 dBHL in the better hearing ear in research period
5) those who are not able to use hearing device for at least two hours in a day for more than a half years
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Omori |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
606-8507
Address
54 Shogoin Kawaharacho, Sakyo, Kyoto
TEL
075-751-3346
omori@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Okano |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Otolaryngology, Head and Neck Surgery
Zip code
606-8507
Address
54 Shogoin Kawaharacho, Sakyo, Kyoto
TEL
075-751-3346
Homepage URL
tokano@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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 | 12 | Month | 20 | 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 | 12 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We aim to find out what type of patients with dementia are recommended to use hearing aid. Results of the present study will contribute to further large clinical trials assessing correlation between cognitive function and hearing impairment.
Management information
Registered date
| 2016 | Year | 12 | Month | 10 | Day |
Last modified on
| 2023 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029001
| Research Plan | |
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| 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 |
