UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054859 |
|---|---|
| Receipt number | R000062683 |
| Scientific Title | Maternal and child sleep test FS01 |
| Date of disclosure of the study information | 2024/07/03 |
| Last modified on | 2025/07/07 10:28:08 |
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Basic information
Public title
Maternal and child sleep measurement
Acronym
Maternal and child sleep measurement
Scientific Title
Maternal and child sleep test FS01
Scientific Title:Acronym
Maternal and child sleep test FS01
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify that improving the sleep environment of infants and toddlers can eliminate the sleep problems and improve the QOL of the infants/toddlers and their parents.
Basic objectives2
Others
Basic objectives -Others
To evaluate changes in sleep and QOL of infants/toddlers and mothers before and after the improvement of sleep environment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Activity amount during sleep of infants/toddlers before and after improvement of sleep environment
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Study participants will choose and perform one/some of the following behaviors that they want to undertake during the feasible period in the test period. There are no restrictions on the number of behaviors/days to be performed, and the participants are asked to perform them within the range that they do not feel burdened
1 Soak up the morning sun after waking up
2 Tone down the lighting from evening to night
3 Blackout the bedroom
4 Play sounds that help to get a good night's sleep
5 Adjust the temperature of the bedroom to 20-22 degree (If it is difficult to adjust to 20-22 degree due to high temperature, set it to around 22-25 degree)
6 Adjust the humidity in the bedroom to 40-60%
7 Create a sleep routine
8 Putting children to bed with an awareness of activity time
The following item should be conscious to the extent that the research participants do not feel burdened
9 Increase the level of happiness of parents and children
In addition, the following items are recommended for safe sleep by study participants (infants)
10 Use a sleeper that matches the season
11 Infants (=under 1 year old) should be laid on their backs
12 Sleep on a futon or bed for babies
13 Do not put anything in the bed (crib) of an infant (=under 1 year old)
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
| 6 | months-old | <= |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1 Infants/toddlers between 6 months and 24 months old and their mothers (18 years old or above)
2 Mothers who have trouble with their children's sleep (6~24 months)
3 Mothers who can attend the seminar in person or on Teams on the designated date
4 Mothers who and/or whose spouses are employees of Kao Corporation/the group companies
5 Mothers who can answer questions about the allergy history and physical condition/medication status for the test period of themselves and the children
6 Those mothers who have off days on Saturdays, Sundays, and public holidays (if they are working)
Key exclusion criteria
1 Infants/toddlers who are expected to undergo major changes in their lives, such as entering a nursery school during the test period
2 Mothers who are expected to undergo major changes in their lives, such as returning to work during the test period
3 Mothers and children who are planning to participate in events that are different from their usual lives, such as trips that involve overnight stays during the test period
4 Infants or mothers who have been diagnosed with sleep disorders or psychiatric illnesses and are currently undergoing treatment
5 Infants/toddlers or mothers who regularly take medication at least once a day
6 Expectant mothers
7 Mothers (or any member of the family who lives together) who have participated in a sleep seminar held by an infant sleep consultant at Kao Corporation in July 2023 and have practiced its'contents
8 Mothers (or any member of the family who lives together) who have received guidance from an infant sleep consultant by the time of obtaining consent and have performed sleep improvement in infants/toddlers
9 When another person in parental authority who lives together is opposed to the infant's participation in the study
10 Infants/toddlers or mothers who are already/plan participating in other studies at the time of receiving the explanation of the study, or who plan to participate in other studies during the test period.
11 Infants/toddlers or mothers who are judged by the Principal Investigator to be inappropriate to participate in the study due to other violations of compliance obligations, etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuuko |
| Middle name | |
| Last name | Fukuda |
Organization
Kao Corporation
Division name
Sanitary Products Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-80-8759-1973
fukuda.yuuko1@kao.com
Public contact
Name of contact person
| 1st name | Yukiyo |
| Middle name | |
| Last name | Eda |
Organization
Kao Corporation
Division name
Sanitary Products Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-80-8759-1973
Homepage URL
tsuge.kyoko@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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 | 07 | Month | 03 | 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
36
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2025 | 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 | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062683
