UMIN-CTR Clinical Trial

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
Email	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
Email	s-kita@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

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)
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044056