UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042370 |
|---|---|
| Receipt number | R000048366 |
| Scientific Title | Effects of improvement of auditory function among older adults: Focusing on gait and cognition |
| Date of disclosure of the study information | 2020/11/10 |
| Last modified on | 2022/12/31 18:48:54 |
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Basic information
Public title
Effects of improvement of auditory function among older adults
Acronym
Effects of improvement of auditory function among older adults
Scientific Title
Effects of improvement of auditory function among older adults: Focusing on gait and cognition
Scientific Title:Acronym
Effects of improvement of auditory function among older adults
Region
| Japan |
Condition
Condition
Hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of hearing aid on gait and cognitive performance, and falls.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait variability
Key secondary outcomes
Cognitive test battery, gait performance, balance performance, and the rate of falls, mental health, social variables
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of hearing aid (at least three months)
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) ADL-independent.
(2) The patient who needs a hearing aid due to hearing loss.
(3) Providing informed consent.
Key exclusion criteria
(1) Not able to walk more than 100 m independently.
(2) Diagnosed as dementia or prescribed anti-dementia agency.
(3) People who are found by medical doctors (co-researchers of this study) to be unable to participate in this program due to significant illness, physical dysfunction, dementia, and neuropsychological disorders etc.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Sakurai |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Social Participation and Community Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi, Tokyo
TEL
03-3964-3241
sakurair@tmig.or.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Sakurai |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Social Participation and Community Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi, Tokyo
TEL
03-3964-3241
Homepage URL
sakurair@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education,Culture,Sports,Science and Technology of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute o Gerontology
Address
35-2, Sakae-cho, Itabashi-ku, Tokyo, Japan
Tel
03-3964-3241
kenkyurinri@tmghig.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
| 2020 | Year | 11 | Month | 10 | 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
10
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
| 2020 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048366
| 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 |
