UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034843 |
|---|---|
| Receipt number | R000039730 |
| Scientific Title | Investigation on the relationship between sleep disorder and diverse development of infants |
| Date of disclosure of the study information | 2018/11/22 |
| Last modified on | 2023/11/13 17:40:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation on the relationship between sleep disorder and diverse development of infants
Acronym
Investigation on the relationship between sleep disorder and diverse development of infants
Scientific Title
Investigation on the relationship between sleep disorder and diverse development of infants
Scientific Title:Acronym
Investigation on the relationship between sleep disorder and diverse development of infants
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the developmental mechanism of autism spectrum disorder (ASD) through integrated analysis of medical and non-medical data of infants with sleep disorder who are known to have some risks for ASD.
Basic objectives2
Others
Basic objectives -Others
Investigation of new biomarkers for ASD
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Infant behavior assessment, infant blood and saliva analysis, assessment of infants' autonomic nervous system, and parents interview of their infants' sleep, sense, and motion.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | months-old | <= |
Age-upper limit
| 60 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants with and without sleep disorder
Key exclusion criteria
Infants with neurological disorders, congenital abnormality, congenital heart or metabolic disorders.
The cases of abusing parents, or parents with mental disorders.
The cases that doctor considered not suitable
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Shoji |
| Middle name | |
| Last name | Itakura |
Organization
Doshisha university
Division name
Center for baby science
Zip code
6190225
Address
4-1-1 Kizugawadai, Kizugawashi, Kyoto-fu
TEL
0774-73-1917
sitakura@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Okuno |
Organization
Doshisha university
Division name
Center for baby science
Zip code
6190225
Address
4-1-1 Kizugawadai, Kizugawashi, Kyoto-fu
TEL
0774-73-1917
Homepage URL
akikookuno258@gmail.com
Sponsor or person
Institute
Center for baby science, Doshisha university
Institute
Department
Personal name
Funding Source
Organization
RIKEN
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Faculty of medicine, Kagawa university
School of medicine, Kurume university
Hyogo prefectural rehabilitation central hospital
Gakkentoshi hospital
Graduate school of letters, Kyoto university
Medical sciences innovation hub program, RIKEN
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Doshisha University Office of Ethics Review
Address
Karasuma-higashi-iru, Imadegawa-dori, Kamigyo-ku, Kyoto-shi 602-8580
Tel
075-251-3158
ji-rinri@mail.doshisha.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
香川大学医学部（香川県）
久留米大学医学部（福岡県）
兵庫県立リハビリテーション中央病院子どもの睡眠と発達医療センター（兵庫県）
学研都市病院小児科（京都府）
理化学研究所医科学イノベーションハブ推進プログラム（東京都、神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | 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
12
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
| 2018 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Cytokines, vitamins etc. in blood and saliva, characteristics of sense/motion/behavior/autonomic nervous system etc. are compared between infants with sleep disorders and healthy subjects.
Management information
Registered date
| 2018 | Year | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039730
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
