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 | 2024/08/27 20:21:52 |
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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
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
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
44
Results
10 patients with DSWPD and 21 healthy subjects who were currently available for analysis were analyzed for EEG spectral analysis. In patients with DSWPD,the slow-wave content of the delta band immediately after the onset of sleep was significantly higher than in healthy subjects. In addition, the slow-wave content of the theta band and the delta band showed almost positive correlation with the score of the MEQ when the ratio of the second half / the first half was taken.
Results date posted
| 2024 | Year | 08 | Month | 27 | Day |
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
Completed
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
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
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
| 2024 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043935
