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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042370
Receipt No. 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 2020/11/06

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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 40

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
Email 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
Email sakurair@tmig.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

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
Email 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
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
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
2020 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048366

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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