UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038562
Receipt number 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 2023/05/18 10:00:31

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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

50


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 or person

Institute

Fujita Health University

Institute

Department

Personal name



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

2023 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

2023 Year 05 Month 18 Day



Link to view the page

Value
https://center6.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