UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032647 |
|---|---|
| Receipt number | R000037210 |
| Scientific Title | Establishment of cognitive and auditory research by gerontologically organized team: Escargot study |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2023/09/06 09:13:31 |
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Basic information
Public title
Establishment of cognitive and auditory research by gerontologically organized team: Escargot study
Acronym
Escargot study
Scientific Title
Establishment of cognitive and auditory research by gerontologically organized team: Escargot study
Scientific Title:Acronym
Escargot study
Region
| Japan |
Condition
Condition
Dementia, Mild cognitive impairment, Auditory disorder, Hearing impairment
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This research will be conducted to elucidate the effect of correction of hearing loss on cognitive function with a particular focus on elderly patients, based on a nationwide, multi-center cohort study in Japan.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to obtain the clinical data regarding the change in cognitive function in elderly patients presenting with hearing loss.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in MMSE from time of enrollment until 2 years after enrollment
Key secondary outcomes
Change in Montreal Cognitive Assessment (MoCA) from time of enrollment until 2 years after enrollment
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
| 55 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who:
1. are between the ages of 55 and 84 years at the time of enrollment
2. have normal cognitive function or mild cognitive impairment or dementia
3. have hearing impairment
Key exclusion criteria
1. Patients unable to undergo MRI examination, or MRI cannot be evaluated due to body movement, etc.
2. Less than or equal to 6 years of education
3. Presenting with hereditary hearing loss, or having artificial cochlea
4. Judged by an investigator to be ineligible to participate as a study subject
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Saji |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Comprehensive Care and Research on Memory Disorders (Department of Stroke Medicine)
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi 474-8511 Japan
TEL
0562-46-2311
sajink@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Saji |
Organization
Center for Comprehensive Care and Research on Memory Disorders, National Center for Geriatrics and G
Division name
Escargot study Secretariat
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi 474-8511 Japan
TEL
0562-46-2311
Homepage URL
sajink@nifty.com
Sponsor or person
Institute
Center for Comprehensive Care and Research on Memory Disorders, National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (2018-2019), Research Funding of Longevity Sciences from the NCGG (2018-2024).
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430, Morioka, Obu, Aichi 474-8511 Japan
Tel
0562-46-2311
yaday@ncgg.go.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
| 2018 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Under registration
Management information
Registered date
| 2018 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037210
| 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 |
