UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063084 |
|---|---|
| Receipt number | R000072217 |
| Scientific Title | Exploration of physical and respiratory function indicators using sensor fusion to quantify the risk of health loss and inform preventive interventions in older adults |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/29 20:22:33 |
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Basic information
Public title
A study using a wearable sensor to measure vocalization frequency in older adults and examine its relationship with physical and respiratory function
Acronym
Voice Tracking Study in Older Adults
Scientific Title
Exploration of physical and respiratory function indicators using sensor fusion to quantify the risk of health loss and inform preventive interventions in older adults
Scientific Title:Acronym
Sensor-Fusion Vocalization Study
Region
| Japan |
Condition
Condition
Healthy adults and community-dwelling older adults
Classification by specialty
| Geriatrics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a wearable sensor-fusion device that extracts the frequency, duration, and intensity (sound pressure) of vocalization from vibration data, to verify its reliability, and to examine the relationships between daily vocalization and physical activity, physical function, and respiratory function in community-dwelling older adults.
Basic objectives2
Others
Basic objectives -Others
Study 1: In 10 healthy adults, the accuracy of distinguishing self-generated from others' vocalization and of separating chewing sounds from vocalization will be verified against video recordings. Study 2: In 6-10 community-dwelling older adults wearing the device during the daytime for 7 days, daily vocalization time, its association with physical activity, and sex differences will be examined. Conversation content will not be recorded or analyzed.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Daily vocalization time measured by the device, and the reliability coefficient for distinguishing self-generated from others' vocalization against video recordings
Key secondary outcomes
Vocalization frequency, vocalization intensity (sound pressure), step count and physical activity, vocal capacity (maximum sound pressure, maximum phonation time), vital capacity, respiratory muscle strength (MIP, MEP), grip strength, skeletal muscle mass index (SMI), Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG-IC), device usability, and adverse events
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Study 1: healthy adult students or staff of Shonan University of Medical Sciences (2) Study 2: community-dwelling older adults living in Kanagawa Prefecture, including residents of Senior Hotel Higashi-Totsuka South Wing, older adults living in Hadano City, and users of Kaze-no-Tani Rehabilitation Day Service (3) Individuals who provided written informed consent
Key exclusion criteria
(1) Severe joint pain in the limbs or trunk (2) Hemiplegia (3) Respiratory disorders (4) A physician's diagnosis of dementia (5) Difficulty understanding instructions
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Morio |
Organization
Shonan University of Medical Sciences
Division name
Department of Rehabilitation, Faculty of Medical Sciences
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama-ctiy, Kanagawa, JAPAN
TEL
+81-45-821-0111
yuji.morio@sums.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Morio |
Organization
Shonan University of Medical Sciences
Division name
Department of Rehabilitation, Faculty of Medical Sciences
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama-ctiy, Kanagawa, JAPAN
TEL
+81-45-821-0111
Homepage URL
yuji.morio@sums.ac.jp
Sponsor or person
Institute
Shonan University of Medical Sciences
Institute
Department
Personal name
Yuji Morio
Funding Source
Organization
NSK Foundation for the Advancement of Mechatronics
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Sasakawa Health Foundation
IRB Contact (For public release)
Organization
Research Ethics Committee of Shonan University of Medical Sciences
Address
16-48, Kamishinano, Totsuka-ku, Yokohama-ctiy, Kanagawa, JAPAN
Tel
+81-45-821-0111
kenkyujimu@sums.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
26-036
Org. issuing International ID_1
Research Ethics Committee of Shonan University of Medical Sciences
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
湘南医療大学、シニアホテル東戸塚サウスウイング、風の谷リハビリデイサービス/ Shonan University of Medical Sciences, Senior Hotel Higashi-Totsuka South Wing, Kaze-no-Tani Rehabilitation Day Service
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study consists of two parts. Study 1 develops a wearable sensor-fusion device (M5Stack-based) and verifies its reliability; Study 2 examines its feasibility in community-dwelling older adults. The device processes only vibration amplitude data, and conversation content is neither recorded nor analyzed. In Study 1, conversations are video-recorded solely for accuracy verification, and the recordings are deleted promptly after verification. All measurement devices are removed in private spaces such as bathrooms and toilets. This approval (No. 26-036) also covers data analysis and publication for a preceding study (approval No. 24-029, UMIN000063074).
Management information
Registered date
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072217
