UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046473 |
|---|---|
| Receipt number | R000053026 |
| Scientific Title | Optimal sleep management for preventing mental illness in adolescents and young adults at risk |
| Date of disclosure of the study information | 2021/12/25 |
| Last modified on | 2024/01/03 11:45:40 |
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Basic information
Public title
Optimal sleep management for preventing mental illness in adolescents and young adults
Acronym
Optimal sleep management for preventing mental illness in adolescents and young adults
Scientific Title
Optimal sleep management for preventing mental illness in adolescents and young adults at risk
Scientific Title:Acronym
Optimal sleep management for preventing mental illness in adolescents and young adults at risk
Region
| Japan |
Condition
Condition
At-risk mental state
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the relationship between sleep-related symptoms and symptoms of psychiatric disorders in the AYA generation.
Basic objectives2
Others
Basic objectives -Others
epidemiological study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(a)Pittsburgh Sleep Quality Index
(b)Smartphone addiction scale
(c)The Structured Interview for Psychosis Risk Syndromes:: SIPS/the Scale of Psychosis Risk Symptoms: SOPS
(d)Sleep related information collected using actigraph:
Total sleep time, sleep efficiency and 24 hour body movement trend.
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
| 15 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Those who can obtain written consent from the individual (including a substitute for those under 20 years of age)
2)Those who are between 15 and 40 years of age at the time of obtaining consent.
3)If the subject is under 20 years of age, a family member over 20 years of age who is aware of the subject's symptoms and living conditions may be present.
4)A person who is attending a psychiatric outpatient clinic and can be diagnosed as ARMS (At-Risk Mental State).
5)A person who possesses the research subject's own smartphone
Key exclusion criteria
1)Those engaged in shift work
2)Persons deemed inappropriate by the principal investigator/associate investigator
3)Persons who are unable to express their intentions clearly
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Nemoto |
Organization
Toho University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
143-8540
Address
Omori-nishi 5-21-6, Ota-ku, Tokyo
TEL
03-3762-4151
takahiro.nemoto@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Tagata |
Organization
Toho University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
143-8540
Address
Omori-nishi 5-21-6, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
hiromi.tagata@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
he Ethical Research Committee of Toho University School of Medicine
Address
Omori-nishi 5-21-6, Ota-ku, Tokyo
Tel
03-3762-4151
med.rinri@ext.toho-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
| 2021 | Year | 12 | 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
| 2020 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 02 | 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
This observational study aims to clarify the relationship between sleep-related symptoms and symptoms of psychiatric disorders in the AYA generation.
Management information
Registered date
| 2021 | Year | 12 | Month | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053026
