UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048059 |
|---|---|
| Receipt number | R000053994 |
| Scientific Title | Research on clinical characteristic of delayed sleep-wake phase disorder without delayed melatonin rhythm |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2023/04/26 19:58:23 |
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Basic information
Public title
Research on clinical characteristic of delayed sleep-wake phase disorder without delayed melatonin rhythm
Acronym
Research on clinical characteristic of delayed sleep-wake phase disorder without delayed melatonin rhythm
Scientific Title
Research on clinical characteristic of delayed sleep-wake phase disorder without delayed melatonin rhythm
Scientific Title:Acronym
Research on clinical characteristic of delayed sleep-wake phase disorder without delayed melatonin rhythm
Region
| Japan |
Condition
Condition
circadian rhythm sleep-wake disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of pathophysiology of circadian rhythm sleep-wake disorder(clinical characteristic)
Basic objectives2
Others
Basic objectives -Others
Elucidation of pathophysiology of circadian rhythm sleep-wake disorder(Homeostasis modulation)
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Characteristics of patients without delayed melatonin rhythm
Key secondary outcomes
Association with comorbidities
Association with refractory
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
| 12 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
<Subjects> DSWPD or N24SWD patients
visiting sleep clinic in Fujita
Health University Hospital,
department of psychiatry
<Healthy person> age-and gendermatched
healthy people
<Subjects>
1. Patients who have received sufficient explanation and who have
given their written consent based
on their own free will
2. Patients who are 12 years old o
r older and graduated from elementary school at the time of consent
3. Patients diagnosed with DSWP
D or N24SWD based on ICSD-3
4.Whether or not there is a comorbidity of mental or physical illness
5.There are no particular restrictions on the current treatment
<Healthy person>
1.Those who have received sufficient explanation and who have given their written consent based on their own free will
2.Patients who are 12 years old or older and graduated from elementary school at the time of consent
3.Those without sleep-wake rhythm disturbance
4.Patients do not have sleep disorders or mental illness based on the diagnostic criteria of ICSD-3 or DSM-5
Key exclusion criteria
<Subjects>
1.Patients with strong suicidal ideation
2.Other patients who are judged
inappropriate by the principal
<Healthy person>
1. Patients with any sleep disorde
r or mental illness based on ICSD-
3 or DSM-5 diagnostic criteria
2.Patients using psychotropic dru
gs such as antipsychotics, antidep
ressants and sleeping pills
3. Other patients who are judged
inappropriate by the research dire
ctor or research director
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | TSUYOSHI |
| Middle name | |
| Last name | KITAJIMA |
Organization
Fujita Health University
Division name
Department of Psychiatry
Zip code
4701192
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi,Japan
TEL
0562-93-2170
tsuyoshi@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | MARINA |
| Middle name | |
| Last name | HIROSE |
Organization
Fujita Health University
Division name
Department of Psychiatry
Zip code
4701192
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi,Japan
TEL
0562-93-2170
Homepage URL
mhirose@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University Research Grant
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethics committee of Fujita Health University
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi,Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2022 | Year | 06 | Month | 30 | 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
| 2021 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Electroencephalogram will be recorded
at home, and melatonin and cortisol in
saliva will be measured.
Management information
Registered date
| 2022 | Year | 06 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053994
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
