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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038562
Receipt No. R000043935
Scientific Title Research on sleep structure and spectral power of sleep electroencephalogram of circadian rhythm sleep-wake disorder
Date of disclosure of the study information 2019/11/12
Last modified on 2020/03/12

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Basic information
Public title Research on sleep structure and spectral power of sleep electroencephalogram of circadian rhythm sleep-wake disorder
Acronym Sleep structure and spectral power of sleep electroencephalogram of circadian rhythm sleep-wake disorder
Scientific Title Research on sleep structure and spectral power of sleep electroencephalogram of circadian rhythm sleep-wake disorder
Scientific Title:Acronym Sleep structure and spectral power of sleep electroencephalogram of circadian rhythm sleep-wake disorder
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(differences in sleep structure with healthy people)
Basic objectives2 Others
Basic objectives -Others Elucidation of pathophysiology of circadian rhythm sleep-wake disorder(differences in spectral power of sleep electroencephalogram with healthy people)
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Differences in sleep structure with
healthy people
Key secondary outcomes -Differences in spectral power of sleep
electroencephalogram with healthy
-Association between spectral power of
sleep electroencephalogram and
melatonin rhythm, and morning cortisol
level

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
70 years-old >
Gender Male and Female
Key inclusion criteria <Subjects> DSWPD 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 15 years old o
r older and graduated from junior
high school at the time of consent
3. Patients diagnosed with DSWP
D based on ICSD-3
4. Based on DSM-5, patients
without other psychiatric disorders
(especially mood disorders,
developmental disorders )
5. In principle, patients without
use of psychotropic drugs
<Healthy person>
1. Those who have received suffic
ient explanation and who have gi
ven their written consent based on
their own free will
2. Those without sleep-wake rhyt
hm disturbance
3. Patients who do not haves sleep
disorders or psychiatric disorders
based on ICSD-3 or DSM-5
Key exclusion criteria <Subjects>
1.Patients with sleep disorders or
psychiatric disorders other than
DSWPD based on ICSD-3 or
DSM-5
2.Patients using psychotropic dru
gs such as antipsychotics, antidep
ressants or hypnotics
3.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 20

Research contact person
Name of lead principal investigator
1st name TSUYOSHI
Middle name
Last name KITAJIMA
Organization School of Medicine
Division name Department of Psychiatry
Zip code 470-1192
Address 1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi,Japan
TEL 0562-93-2170
Email tsuyoshi@fujita-hu.ac.jp

Public contact
Name of contact person
1st name MARINA
Middle name
Last name HIROSE
Organization School of Medicine
Division name Department of Psychiatry
Zip code 470-1192
Address 1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi,Japan
TEL 0562-93-2170
Homepage URL
Email mhirose@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
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 the ethics committee of Fujita Health University
Address 1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi,Japan
Tel 0562-93-2865
Email 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
2019 Year 11 Month 12 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 05 Month 13 Day
Date of IRB
2019 Year 10 Month 17 Day
Anticipated trial start date
2019 Year 11 Month 13 Day
Last follow-up date
2021 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
2019 Year 11 Month 12 Day
Last modified on
2020 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043935

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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