UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038659 |
|---|---|
| Receipt number | R000044056 |
| Scientific Title | Contributions of sleep homeostasis and circadian rhythms on children's sleep regulation |
| Date of disclosure of the study information | 2019/11/22 |
| Last modified on | 2019/11/22 00:35:41 |
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Basic information
Public title
Relationship between wake duration and rhythm and children's sleep
Acronym
Relationship between wake duration and rhythm and children's sleep
Scientific Title
Contributions of sleep homeostasis and circadian rhythms on children's sleep regulation
Scientific Title:Acronym
sleep homeostasis and circadian rhythm in children
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the contributions of both homeostatic sleep function and circadian rhythms on sleep onset timing in children around puberty
Basic objectives2
Others
Basic objectives -Others
To evaluate the contributions of both homeostatic sleep function(Subjective sleepiness, reaction time, EEG) and circadian rhythms(peripheral heat loss, melatonin onset timing, chronotype) on sleep onset timing in children around puberty
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
standard partial regression coefficients of both homeostatic sleep function and circadian rhythms on sleep onset timing
Key secondary outcomes
Sleep parameters (total sleep time, total time of each sleep stage, sleep latency, number of awakening, wake time after sleep onset, number of sleep stage transitions, number of sleep cycles, EEG power spectrum density)
Subjective sleepiness
Subjective sleep quality
Correlation of sleep homeostasis function and circadian rhythm function with age
Phase angle between melatonin onset time and sleep time
Relationship between sleepiness and thermoregulatory changes in each age
Habitual sleep parameters
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Forced wake until one hour after of habitual bed time under dim light condition (<10lux)
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 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy children (boys and girls) aged 6 to 15 years old
Key exclusion criteria
History of major disorder which possibly affect results
History of drugs which possibly affect results
Traveling across time zones within 6 months
Unable to sleep in laboratory
Others who the researcher judged inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kitamura |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders
Zip code
187-8553
Address
4-1-1, Ogawa-Higashi, Kodaira
TEL
042-346-2014
s-kita@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kitamura |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Sleep-Wake Disorders
Zip code
187-8553
Address
4-1-1, Ogawa-Higashi, Kodaira
TEL
042-346-2014
Homepage URL
s-kita@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the National Center of Neurology and Psychiatry
Address
4-1-1, Ogawa-Higashi, Kodaira
Tel
042-341-2712(7828)
ml_rinrijimu@ncnp.go.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
| 2019 | Year | 11 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 22 | 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
| 2019 | Year | 11 | Month | 22 | Day |
Last modified on
| 2019 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044056
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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