UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055828 |
|---|---|
| Receipt number | R000063808 |
| Scientific Title | An Exploratory Study of Sleep Measurement and Sleep Improvement in Obu City |
| Date of disclosure of the study information | 2024/10/14 |
| Last modified on | 2025/04/28 18:20:34 |
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Basic information
Public title
An Exploratory Study of Sleep Measurement and Sleep Improvement in Obu City
Acronym
Sleep test
Scientific Title
An Exploratory Study of Sleep Measurement and Sleep Improvement in Obu City
Scientific Title:Acronym
Sleep test
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
-Screening using a wearable activity meter and a sleep questionnaire, and a sleep test using a wearable EEG measuring device to measure brain waves and other data from sleeping to waking in the home environment were conducted for employees at business sites in Obu City. (The progress and condition of sleep are measured and evaluated, and the patients are classified into three groups: Group A (healthy sleep), Group B (no major problems, but lifestyle and sleep habits need attention), Group C (sleep improvement needed), and Group D (sleep disorder suspected).
-Workers who need to improve their sleep will be provided with a sleep improvement application, and after one month their sleep will be measured with a wearable EEG measurement device to evaluate the effect of the sleep improvement application on their sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes on sleeping
Key secondary outcomes
Questionnaire
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
| Other |
Interventions/Control_1
Have them use a sleep improvement app (2-week program)
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Healthy men and women, 20 years old and over, under 75 years old.
-Subjects who can make self-judgment and arevoluntarily giving written informed consent.
Key exclusion criteria
-Subjects who fall into Group A, B, or D according to grouping by sleep test using a wearable EEG measurement device.
-Those who have been diagnosed with insomnia, sleep apnea, or other sleep disorders and are taking drugs such as sleep inducers or insomnia medications (including OTC drugs as well as prescription drugs) or are receiving treatment with CPAP, mouthpieces, or the like.
-Working late at night or in rotating shifts.
-Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Shoji |
Organization
Nagase & Co., Ltd.
Division name
Section Manager, Product Strategy Section, Pharma Medical Dept.
Zip code
550-8668
Address
1-1-17 Shinmachi, Nishi-ku, Osaka 550-8668, Japan
TEL
+81-6-6535-2327
yusuke.shoji@nagase.co.jp
Public contact
Name of contact person
| 1st name | Chiemi |
| Middle name | |
| Last name | Tanigawa |
Organization
S'UIMIN INC.
Division name
Research Support Division
Zip code
151-0061
Address
817, Hatsudai Center Bldg. 1-51-1, Hatsudai Shibuya-ku, Tokyo, 151-0061, JAPAN
TEL
+81-3-6276-3662
Homepage URL
c.tanigawa@suimin.co.jp
Sponsor or person
Institute
Nagase & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nagase & 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
+81-3-5297-5548
IRB@cpcc.co.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
| 2024 | Year | 10 | Month | 14 | 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
53
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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063808
