UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049888 |
|---|---|
| Receipt number | R000056756 |
| Scientific Title | Visualization of Sleep Structure Using Sleep Electroencephalography in Association with Well-Being |
| Date of disclosure of the study information | 2022/12/27 |
| Last modified on | 2022/12/23 14:23:14 |
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Basic information
Public title
Visualization of Sleep Structure Using Sleep Electroencephalography in Association with Well-Being
Acronym
Visualization of Sleep Structure Using Sleep Electroencephalography in Association with Well-Being
Scientific Title
Visualization of Sleep Structure Using Sleep Electroencephalography in Association with Well-Being
Scientific Title:Acronym
Visualization of Sleep Structure Using Sleep Electroencephalography in Association with Well-Being
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sleep state and structure will be measured using a portable sleep electroencephalograph (InSomnograf) in healthy participants over 20. This study aims to clarify the relationship between sleep structure and well-being by comparing the results of these measurements with an evaluation scale of well-being.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indicators obtained from sleep electroencephalograph data [InSomnograf (S'UIMIN Co., Ltd.)] [Time (min) of each sleep stage (REM, N1, N2, N3), Occurrence Rate (%TST), REM latency (min), Median sleep time, Total time awake after falling asleep (sec), Number of awakening responses (times), etc.]
Key secondary outcomes
1) Satisfaction With Life Scale (SWLS)
2) Scale of Positive and Negative Experience(SPANE-J)
3) Flourishing Scale (FS-J)
4) Subjective Happiness Scale (SHS)
5) The Japanese version of the Pittsburgh Sleep Quality Index (PSQI-J)
6) Epworth Sleepiness Scale (JESS)
7) Daily positive/negative emotions, happiness, sleep duration, sleep quality, smartphone usage, etc.
8) Perceived Stress Scale (PSS)
9) Patient Health Questionnaire-9 (PHQ-9)
10) State-Trait Anxiety Inventory (STAI)
11) Indicators obtained from activity meter data [MTN-220 / MTN-221 (Kissei Comtec Corporation)] (sleep status, number of steps, total calories consumed and activity calories burned,etc.)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Participants with no history of mental disorders (no previous medical diagnosis of mental disorders) who volunteered to cooperate in the study after seeing the recruitment advertisement.
2) 20 years of age or older
Key exclusion criteria
1) Participants may have difficulty attaching the sleep electroencephalograph (InSomnograf) due to skin hypersensitivity or other reasons.
2) Participants suffering from some physical disease that may affect data acquisition (e.g., forehead skin disease or skull defects, persons currently suffering from sleep disorders, or persons with paralysis or involuntary movements of the limbs).
3) Participants undergoing treatment that is likely to cause significant effects on brain waves or body movements (e.g., treatment for brain tumors, stroke, epilepsy, or disorders of consciousness).
4) Participants with markedly disturbed sleep-wake patterns (e.g., late-night workers, shift workers, etc.)
5) Participants who have difficulty with computer operations such as receiving e-mails, web input, remote communication connections, etc.
6) Other cases in which the researcher deems them unsuitable.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kiko |
| Middle name | |
| Last name | Shiga |
Organization
Shigakukan University
Division name
Department of Clinical Psychology
Zip code
8908504
Address
59-1 Murasakibaru, Kagoshima-shi, Kagoshima
TEL
0998128505
kiko.shiga@shigakukan.ac.jp
Public contact
Name of contact person
| 1st name | Kiko |
| Middle name | |
| Last name | Shiga |
Organization
Shigakukan University
Division name
Department of Clinical Psychology
Zip code
8908504
Address
59-1 Murasakibaru, Kagoshima-shi, Kagoshima
TEL
0998128505
Homepage URL
kiko.shiga@shigakukan.ac.jp
Sponsor or person
Institute
Department of Clinical Psychology, ShigakukanUniversity.
Institute
Department
Personal name
Funding Source
Organization
Shigakukan University
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 committees of Shigakukan University School
Address
59-1 Murasakibaru, Kagoshima-shi, Kagoshima
Tel
0998128505
soumu@shigakukan.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 | 12 | Month | 27 | 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
| 2022 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A.
Management information
Registered date
| 2022 | Year | 12 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056756
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