UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048136 |
|---|---|
| Receipt number | R000054853 |
| Scientific Title | Relationship between delayed sleep-wake phase disorder and domains of attentional function |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2024/04/01 15:27:46 |
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Basic information
Public title
Relationship between delayed sleep-wake phase disorder and domains of attentional function
Acronym
Relationship between DSWPD and attentional function
Scientific Title
Relationship between delayed sleep-wake phase disorder and domains of attentional function
Scientific Title:Acronym
Relationship between DSWPD and attentional function
Region
| Japan |
Condition
Condition
Delayed sleep-wake phase disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the relationship between delayed sleep-wake phase disorder and domains of attentional function.
Basic objectives2
Others
Basic objectives -Others
association study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of DSWPD and domains of attention function
Key secondary outcomes
Assessment of sleep-wake rhythms and circadian rhythms, developmental disability characteristics, psychiatric assessment
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
| 16 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Is above 16 years and below 30 years old at the time of agreement
2.Meets the diagnostic criteria for DSWPD of DSM-5 or ICSD-3.
3.Admitted to our hospital due to inadequate response to standard outpatient treatment.
Key exclusion criteria
1.Meets the diagnostic criteria of severe mental retardation or dementia
2.Has imminent thoughts of death
3.Working in shifts, or traveling abroad for less than one month.
4.Any patients whom the study investigator find inappropriate to include in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Matsui |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Laboratory Medicine
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
0423462014
matsui.kentaro@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Nagao |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Psychiatry
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL
0423462014
Homepage URL
knagao@ncnp.go.jp
Sponsor or person
Institute
National Center Hospital, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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, National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel
0423412712
rinri-jimu@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
| 2022 | Year | 07 | Month | 01 | 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
| 2020 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate the relationship between seviality of DSWPD and domains of attentional function in adolescence.
Management information
Registered date
| 2022 | Year | 06 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054853
