UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048683 |
|---|---|
| Receipt number | R000055178 |
| Scientific Title | Development of an interactive application to improve sleep habits of young children 2nd |
| Date of disclosure of the study information | 2022/08/25 |
| Last modified on | 2025/02/17 11:11:58 |
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Basic information
Public title
Development of an application to support healthy sleep and parenting for young children
Acronym
Development of an application to support healthy sleep of young children
Scientific Title
Development of an interactive application to improve sleep habits of young children 2nd
Scientific Title:Acronym
Development of an application to improve sleep habits of young children 2nd
Region
| Japan |
Condition
Condition
Poor sleep habits of young children
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the feasibility of implementing this app in community use
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Drop-out rate after 6 months
Key secondary outcomes
Sleep parameters ( e.g., sleep onset latency) after 6 months
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
| Behavior,custom |
Interventions/Control_1
Intervention with an application using an automatic analysis and guidance system for sleep habits in young children (6 months, 6 times intervention in total)
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 | months-old | <= |
Age-upper limit
| 36 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Target age: Children over 1.5 years old and under 3 years old.
Caregivers who are 20 years of age or older
Caregivers are able to use LINE on a smartphone or other devices
The child must meet one of the following conditions
1.Delayed bedtime
2.Short nighttime sleep duration
3.Frequent nighttime awakenings
4.Inconsistent sleep-wake rhythm
5.None of the above, but the child's caregiver wishes to receive sleep health education.
Key exclusion criteria
Pregnant caregivers
Caregivers with known or suspected child abuse, caregivers with mental illness or other difficulties in cooperating in research
The device using LINE frequently reaches a communication limit.
Those who are identified by the principal investigator or research associate as being unsuitable to participate in the research for other reasons.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Arika |
| Middle name | |
| Last name | YOSHIZAKI |
Organization
Osaka University
Division name
Molecular Research Center for Children's Mental Development, United Graduate School of Child Development
Zip code
5650871
Address
2-2-D5 Yamadaoka, Suita City, Osaka, Japan
TEL
06-6879-3863
arika@kokoro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Arika |
| Middle name | |
| Last name | YOSHIZAKI |
Organization
Osaka University
Division name
Molecular Research Center for Children's Mental Development
Zip code
5650871
Address
2-2-D5 Yamadaoka, Suita City, Osaka, Japan
TEL
06-6879-3863
Homepage URL
arika@kokoro.med.osaka-u.ac.jp
Sponsor or person
Institute
Molecular Research Center for Children's Mental Development, United Graduate School of Child Development, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hirosaki University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Osaka University Hospital
Address
2-2-4F, Yamadaoka, Suita City, Osaka, Japan, 565-0871
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.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
| 2022 | Year | 08 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2022 | Year | 08 | Month | 17 | Day |
Last modified on
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055178
