UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038804 |
|---|---|
| Receipt number | R000044239 |
| Scientific Title | Analysis of cognitive and auditory function in community-dwelling older persons: a population-based study |
| Date of disclosure of the study information | 2019/12/10 |
| Last modified on | 2023/09/06 09:11:47 |
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Basic information
Public title
Analysis of cognitive and auditory function in community-dwelling older persons: a population-based study
Acronym
Analysis of cognitive and auditory function in community-dwelling older persons: a population-based study
Scientific Title
Analysis of cognitive and auditory function in community-dwelling older persons: a population-based study
Scientific Title:Acronym
Analysis of cognitive and auditory function in community-dwelling older persons: a population-based study
Region
| Japan |
Condition
Condition
cognitive and auditory function
Classification by specialty
| Neurology | Geriatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research will be conducted to analyze cognitive and auditory function in community-dwelling older persons.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to obtain the data regarding the cognitive function in community-dwelling older persons presenting with hearing loss.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cognitive and auditory function
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
| 55 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who:
1. answered to the questionnaire survey regarding hearing loss
2. are between the ages of 55 and 99 years at the time of enrollment
Key exclusion criteria
1. Refusal to participate this study
2. Incomplete answer to the questionnaire survey
3. Judged by an investigator to be ineligible to participate as a study subject
Target sample size
2000
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
Research Funding of Longevity Sciences from the NCGG
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2019 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0167494320302995
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncgg.go.jp/hospital/monowasure/news/20201130.html
Number of participants that the trial has enrolled
1602
Results
We analyzed 1602 eligible participants. Hearing aid users (n = 90) were older (80 vs. 73 years, respectively; p < 0.001) and less likely to draw the clock correctly (71.1% vs. 80.1% years, respectively; p = 0.044) than non-hearing aid users. Multivariate logistic regression analysis showed that HI was associated with inability to draw the clock correctly (odds ratio 1.60, 95% confidence interval 1.12-2.26; p = 0.011), independent of age, living alone, memory impairment, and impaired self-care levels.
Results date posted
| 2023 | Year | 06 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 11 | Month | 27 | Day |
Baseline Characteristics
Participants enrolled in the Itabashi cohort or the Tarumizu cohort were eligible for this retrospective analysis if they met the following criteria: (1) age more than 65 years; (2) provided written informed consent to participate in the community-based cohort study; and (3) provided informed consent regarding this secondary analysis of their data.
Participant flow
Participants enrolled in the Itabashi cohort or the Tarumizu cohort were eligible for this retrospective analysis
Adverse events
none.
Outcome measures
All participants underwent a comprehensive geriatric assessment that measured the following: (1) demographic characteristics; (2) risk factors including hypertension, dyslipidemia, diabetes mellitus, ischemic heart disease, a history of stroke, and a smoking habit; (3) cognitive function; (4) hearing condition; (5) lifestyle including a habit of physical exercise and sleep condition; (6) self-care levels based on the classification of the Long-Term Care Insurance (LTCI) system in Japan16; and (7) the number of family members living together (living alone or not).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
in preparation
Management information
Registered date
| 2019 | Year | 12 | Month | 05 | 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=R000044239
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| Research case data | |
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