UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060314 |
|---|---|
| Receipt number | R000068996 |
| Scientific Title | Effect of the presence or absence of a communication support device on cognitive function testing in patients with hearing loss |
| Date of disclosure of the study information | 2026/01/10 |
| Last modified on | 2026/01/10 03:32:12 |
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Basic information
Public title
Effect of a communication support device on cognitive function testing in patients with hearing loss
Acronym
Communication support device and cognitive function testing in patients with hearing loss
Scientific Title
Effect of the presence or absence of a communication support device on cognitive function testing in patients with hearing loss
Scientific Title:Acronym
Presence or absence of a communication support device and cognitive function testing in patients with hearing loss
Region
| Japan |
Condition
Condition
inpatients
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of using a communication support device for Mini-Mental State Examination in patients with hearing loss
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of MMSE-J Scores with and without a communication support device in patients with hearing loss
Key secondary outcomes
MMSE-J score
Visual Analog Scale(VAS)
Raven's Coloured Progressive Matrices (RCPM)
Pure tone audiometry
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
MMSE-J, VAS, and RCPM test with a communication support device.
Interventions/Control_2
MMSE-J, VAS, and RCPM test without a communication support device.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were able to perform the cognitive function testing.
Patients who could sit on a chair during testing.
Key exclusion criteria
Patients who are unable to follow the therapists' instructions adequately.
Patients who are expected to be discharged within two weeks.
Patients who were discharged or transferred to another ward due to sudden deterioration before the final evaluation.
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562-46-2311
hkagaya2@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562-46-2311
Homepage URL
hkagaya2@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
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
The Ethics Review Board, National Center for Geriatric and Gerontology
Address
7-430 Morioka-cho, Obu, Aichi
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
| 2026 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 10 | 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
| 2026 | Year | 01 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068996
