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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025213
Receipt No. 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 2016/12/10

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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
Middle name
Last name Koichi Omori
Organization Kyoto University, Graduate School of Medicine
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address 54 Shogoin Kawaharacho, Sakyo, Kyoto
TEL 075-751-3346
Email omori@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Okano
Organization Kyoto University, Graduate School of Medicine
Division name Department of Otolaryngology, Head and Neck Surgery
Zip code
Address 54 Shogoin Kawaharacho, Sakyo, Kyoto
TEL 075-751-3346
Homepage URL
Email tokano@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 20 Day
Last follow-up date
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
2016 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029001

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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