UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062424 |
|---|---|
| Receipt number | R000071436 |
| Scientific Title | Clinical verification of the effects of AI-equipped radio on well-being and communication promotion in elderly care facilities |
| Date of disclosure of the study information | 2026/07/31 |
| Last modified on | 2026/07/31 15:10:51 |
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Basic information
Public title
Clinical verification of the effects of AI-equipped radio on well-being and communication promotion in elderly care facilities
Acronym
AIR-WELL
Scientific Title
Clinical verification of the effects of AI-equipped radio on well-being and communication promotion in elderly care facilities
Scientific Title:Acronym
AIR-WELL-Study
Region
| Japan |
Condition
Condition
Elderly nursing home residents
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clinically verify the possibility that past news and music provided by AI-powered radios evoke memories, leading to positive changes in residents' psychological well-being and quality of life (QOL). Additionally, to evaluate changes in the quantity and quality of communication among residents and staff to clarify its contribution to promoting daily enjoyment and mutual understanding
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the scores of behavioral and psychological symptoms of dementia scales (NPI and DBD13) before and after using the AI-powered radio (during each 20-minute interaction session)
Key secondary outcomes
1.Changes in communication behavior indicators (comparison between 20-minute sessions before and after use): Number of clauses, total conversation turns (including backchanneling), proactive speech turns, conversation participation time (speaking and listening), pitch range, speech rate, and content word counts by part of speech
2.Changes in facial expression indicators (comparison between 20-minute sessions before and after use): Quantification of 20 types of facial muscle action units and basic emotions (joy, sadness, anger, fear, disgust, surprise, contempt, neutral) using Face Reader
3.Qualitative changes in conversation content: Analysis of the frequency and nature of emotional expressions and adjective usage
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A single dialogue session using the AI-powered radio "RADIO TIME MACHINE" is conducted for approximately 20 minutes.The AI plays news and hit songs from a specific year (1950-2025) selected by the participant via a dial, facilitating reminiscence-based dialogue and communication among residents and with staff.
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
| 60 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Individuals aged 60 or older residing in elderly care facilities
2.Those who responded to the recruitment and provided voluntary written informed consent, either by themselves or through a legal representative
Key exclusion criteria
1.Individuals with a history of hearing impairment
2.Others deemed inappropriate for study participation by the researcher
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Michinari |
| Middle name | |
| Last name | Fukuda |
Organization
Kitasato University
Division name
School of Allied Health Sciences, Department of Rehabilitation, Program in Occupational Therapy
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-9971
mifukuda@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Michinari |
| Middle name | |
| Last name | Fukuda |
Organization
Kitasato University
Division name
School of Allied Health Sciences, Department of Rehabilitation, Program in Occupational Therapy
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
042-778-9971
Homepage URL
mifukuda@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Michinari Fukuda
Funding Source
Organization
TBWA HAKUHODO Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
TBWA HAKUHODO Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office of Research Ethics Committee, School of Allied Health Sciences, Kitasato University
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
Tel
042-778-7756
mifukuda@kitasato-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025-043
Org. issuing International ID_1
Kitasato University School of Allied Health Sciences Research Ethics Committee
Study ID_2
C-T2026-0290
Org. issuing International ID_2
Kitasato University Conflict of Interest Committee
IND to MHLW
Institutions
Institutions
ニチイケアセンター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 31 | 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
| 2023 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
This is a single-arm intervention study comparing before and after the introduction of an AI-powered radio in the same subjects. The intervention is conducted as a single session of approximately 20 minutes, and no long-term follow-up is planned.
Management information
Registered date
| 2026 | Year | 07 | Month | 31 | Day |
Last modified on
| 2026 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071436
