UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063295 |
|---|---|
| Receipt number | R000072441 |
| Scientific Title | A Before-and-After Comparison Study of the Usability, Acceptability, and Sleep-Related Measures of WillSleep in Real-World Use -A Prospective, Single-Arm, 6-Week Real-World Use Study of WillSleep- |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/10/15 15:57:29 |
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Basic information
Public title
A Before-and-After Comparison Study of the Usability, Acceptability, and Sleep-Related Measures of WillSleep in Real-World Use
-A Prospective, Single-Arm, 6-Week Real-World Use Study of WillSleep-
Acronym
A Before-and-After Comparison Study of the Usability, Acceptability, and Sleep-Related Measures of WillSleep in Real-World Use
-A Prospective, Single-Arm, 6-Week Real-World Use Study of WillSleep-
Scientific Title
A Before-and-After Comparison Study of the Usability, Acceptability, and Sleep-Related Measures of WillSleep in Real-World Use
-A Prospective, Single-Arm, 6-Week Real-World Use Study of WillSleep-
Scientific Title:Acronym
A Before-and-After Comparison Study of the Usability, Acceptability, and Sleep-Related Measures of WillSleep in Real-World Use
-A Prospective, Single-Arm, 6-Week Real-World Use Study of WillSleep-
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to exploratorily evaluate changes in usability, acceptability, adherence to use, NeuroTx's proprietary sleep assessment measures, and wearable device integration data following six weeks of WillSleep use in a real-world setting in Japan. In addition, this study aims to collect real-world use data to understand users' experiences and operational challenges in Japan and to assess the potential applicability of WillSleep to the Japanese market.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Assessment of the usability and acceptability of WillSleep.
2.Adherence to WillSleep use during the six-week real-world use period, including the number of days of use, frequency of use, consecutive days of non-use, and server synchronization status.
3.Changes in the sleep risk score(0-100 points)derived from NeuroTx's proprietary sleep assessment questionnaire at baseline, Week3, and Week6.
Key secondary outcomes
1.Sleep, pulse rate, heart rate variability(HRV), peripheral oxygen saturation(SpO2), physical activity, and other measures obtained from the wearable device, as well as data collection status.
2.Technical issues related to integration among WillSleep, the application, and the wearable device.
3.Safety-related information, including adverse events and skin symptoms at the device-wearing site.
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Wearable Devices
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese men and women aged 20 to 59 at the time of obtaining web consent.
2.Subjects who habitually experience dissatisfaction with their sleep.
3.Subjects who are selected as eligible candidates following a sleep risk assessment using NeuroTx's proprietary sleep assessment questionnaire.
4.Subjects who own a smartphone running Android 10 or later or iOS 15 or later, with Bluetooth Low Energy(BLE)and internet connectivity available, and who are able to complete web-based questionnaires.
5.Subjects whose smartphones are capable of integration with Google Play Services and Health Connect on Android devices, or with Apple Health on iOS devices.
6.Subjects who are able to use WillSleep and the wearable device at home for six weeks during the study period and comply with the procedures specified for the study.
7.Subjects who have been fully explained the purpose and contents of the study, are capable of consenting, fully understand the content, and voluntarily volunteer to participate in the study and agree to participate in the study.
Key exclusion criteria
1.Subjects who have been diagnosed with dementia or who have difficulty adequately understanding the study procedures, informed consent, or instructions for using the study device.
2.Subjects who use a pacemaker.
3.Subjects with heart disease, arrhythmias, or other cardiovascular conditions.
4.Subjects with neurological disorders, such as epilepsy.
5.Subjects who are currently receiving medication or outpatient treatment for any serious medical condition.
6.Subjects who regularly use sleeping pills, anxiolytics, antidepressants, or other medications that may affect sleep.
7.Subjects who have wounds, inflammation, eczema, or other skin conditions at the site where the study device is to be worn, or who have allergies, sensitive skin, or other conditions that may increase the risk of developing dermatitis or other skin reactions due to wearing the study device.
8.Subjects with current or past drug or alcohol dependence.
9.Subjects who are currently receiving medical care for psychiatric disorders(e.g., depression)or sleep disorders(e.g., insomnia or obstructive sleep apnea), or who have a history of psychiatric disorders.
10.Subjects who are currently pregnant or breastfeeding, or who may become pregnant during the study period.
11.Subjects who have difficulty complying with the study procedures, using the application, or completing the scheduled assessments.
12.Subjects who are otherwise deemed ineligible to participate in the study by the principal investigator or the contract research organization for safety-related or study implementation reasons.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Hyunjong |
| Middle name | |
| Last name | Kim |
Organization
NeuroTx Co., Ltd.
Division name
Director
Zip code
02559
Address
Room 1525, Tower Building, Cheongnyangni Station Lotte Castle SKY-L65, 200 Wangsan-ro, Dongdaemun-gu, Seoul, Republic of Korea
TEL
+82-2-3290-3617
khjcoo@neurotx.org
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
MIS Co.,Ltd.
Division name
Clinical Development Department
Zip code
531-0072
Address
8F,Sho-rei Building, 3-4-14 Toyosaki, Kitaku, Osaka-Shi, Osaka, 531-0072, Japan
TEL
06-7878-6780
Homepage URL
mis_21@mis21.co.jp
Sponsor or person
Institute
MIS Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
NeuroTx Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
DiaStep Medical Corporation Home Doctor Clinical Research Ethics Review
Address
3F, Morizumi Building, 22-7 Taishido 4-chome, Setagaya-ku, Tokyo
Tel
03-5433-3255
tomohisa.kato@diastep.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 | 10 | Month | 16 | 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 | 10 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 18 | 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 | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072441
