UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051736 |
|---|---|
| Receipt number | R000059046 |
| Scientific Title | Dream Emotion Recognition during Sleep Using High Density Electroencephalogram Signals |
| Date of disclosure of the study information | 2023/07/28 |
| Last modified on | 2023/07/28 10:47:38 |
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Basic information
Public title
Dream Emotion Recognition during Sleep Using High Density Electroencephalogram Signals
Acronym
Dream Emotion Recognition
Scientific Title
Dream Emotion Recognition during Sleep Using High Density Electroencephalogram Signals
Scientific Title:Acronym
Dream Emotion Recognition
Region
| Japan |
Condition
Condition
Healty adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to improve our understanding of the neural mechanisms involved in the emotional content of dreams and provide a new experimental protocol in the field of dream research to obtain the emotional content of dreams.
Basic objectives2
Others
Basic objectives -Others
Model Evaluation in Machine Learning
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The F-score is utilized to evaluate the predictive performance of the machine learning model on the emotional valence and arousal of dreams containing emotions.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
Presentation of emotional videos and dream recall during sleep
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
| 19 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Those who can read and write documents in English and have no difficulty speaking English.
-Those who could stay in the laboratory on the fifth floor of the University of Tsukuba Medical Innovation Medical Research Institute.
Key exclusion criteria
1. Individuals with an irregular lifestyle, characterized by deviating sleep patterns from the conventional schedule of going to bed between 9 PM and 1 AM and waking up between 6 AM and 9 AM
2. Underweight (BMI less than 18.5) or overweight (BMI greater than 25)
3. Worked night shift (after 10 PM) within the past 3 months
4. Traveled to a country with a time difference of more than 3 h within the past 3 months
5. Habitual alcohol drinkers (more than 40 g of pure alcohol [approximately two cans of beer] at least twice per week).
6. Smoking habituated
7. Consume more than 300 mg of caffeine daily (approximately five cups of 150 mL coffee).
8. Individuals with a score of 38 or more on the Trait Anxiety Scale of the State Trait Anxiety Inventory (STAI)
9. Individuals with a score of 14 or more on the Beck Depression Inventory (BDI II)
10. Individuals with a score of 6 or more on the Pittsburgh Sleep Quality Index
11. Have claustrophobia.
12. Pregnant or possibly pregnant women
13. Breastfeeding individuals
14. Have an illness or a history of an illness with the potential for sudden changes
15. Patients who have received treatment for psychiatric symptoms or sleep disorders or who currently have symptoms and are subject to treatment. Individuals who have previously or are currently taking prescription medication for mental disorders or sleep disorders. Individuals who meet all the selection criteria and do not fall under the exclusion criteria 1 to 14 will be referred to a psychiatrist. The psychiatrist will make the decision regarding participation in the experiment based on the screening information. Additionally, if required, we may conduct interviews, and individuals deemed unsuitable will be excluded from the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine
Zip code
305-8550
Address
1-2 Kasuga, Tsukuba, Ibaraki
TEL
029-859-1469
abe.takashi.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Abe |
Organization
University of Tsukuba
Division name
International Institute for Integrative Sleep Medicine
Zip code
305-8550
Address
1-2 Kasuga, Tsukuba, Ibaraki
TEL
029-859-1469
Homepage URL
abe.takashi.gp@u.tsukuba.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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 Clinical Research Ethics Review Committee of the University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-5876, Japan
Tel
029-853-3914
rinshokenkyu@un.tsukuba.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
| 2023 | Year | 07 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059046
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| Registered date | File name |
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