Healthy subjects
Conditions
Interventions
This is an interventional study that does not fall under the category of preventive, diagnostic, or therapeutic methods using drugs or medical devices. The duration of the intervention is one day. Th
Sponsors
University of Tsukuba International Institute for Integrative Sleep Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be included in the following all criteria. 1) Having no difficulty in filling out Japanese explanatory documents, consent forms, and survey forms 2) No claustrophobia and being able to stay in the examination room on the 5th floor of the Innovative Medical Research Institute, University of Tsukuba. 3) Having no sleep disorder currently being treated 4) Having no hearing impairment in daily life 5) High scores of State-Trait Anxiety Inventory - subscale scores of trait anxiety (45-80 point)
Exclusion criteria
Exclusion criteria: Participants will be excluded from the experiment based on the following criteria. 1)BMI less than 18.5 or greater than 25 2)Worked night shifts (after 10pm) 3 months prior to the experiment 3) Travel across time zones with time Difference of 3 hours or more, 3 months prior to the experiment 4) Consumes alcohol regularly (40g (2 cans of beer) or more twice a week a more) 5)Smoker 6) Consumes more than 400 mg (Based on the maximum caffeine intake of healthy adults without adverse effects [European Food Safety Authority, Health Canada],5 cups of 150mL) of coffee every day 7) MEQ score of less than 30 (extreme evening type) or greater than 70 (extreme morning type) 8) Those who cannot perceive the auditory stimulation and feel uncomfortable when listening to samples of this experiment. 9) Pregnancy or its possibility 10) Lactation 11) Those who have a disease that may change suddenly or its history 12) Those who have been treated for psychiatric disorders or sleep disorders, and those who have symptoms that are currently being treated 13)Candidates of Participants who follow all inclusion criteria, but exclusion criteria 1) -12) will be reported to psychiatrist. Psychiatrist interviews as needed to determine the unsuitable person as a subject. 14) Subjects judged by the principal investigator to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) We will evaluate the EEG measurement device made by S'UIMIN Co., Ltd. in terms of wearability, effect on sleep, data characteristics in use environment, and signal-to-noise ratio. Furthermore, a performance verification test will be conducted by simultaneous measurement with PSG, and the characteristics and accuracy of each biological signal will be compared with the standard method to evaluate the equivalence. 2) Visual sleep staging will be performed by a clinical laboratory technician certified by the Japanese Society of Sleep Research after data acquisition of biometric information obtained from S'UIMIN's EEG measurement device and polysomnography EEG, electroretinogram, electromyogram, etc. collected during normal sleep and parameters such as lights-out time. The result is taken as the correct answer, and the judgment accuracy and agreement rate are calculated. 3) We will begin development of a program to automatically perform sleep staging by analyzing biopotential data such as EEG during sleep, referring to existing data from PSG tests and simple electroencephalographs. We will optimize the algorithm, the structure of the analysis system, and the analysis parameters, etc., in order to improve the judgment accuracy and agreement rate by comparing the analysis results of the program with those of clinical technologists certified by the Japanese Society of Sleep Research. 4) Once the judgment accuracy and agreement rate reach the target, optimize the algorithm, the structure of the analysis system, and the analysis parameters in order to improve the accuracy and agreement rate of the sleep staging judgment of the data acquired using the EEG measurement device manufactured by S'UIMIN Co. | — |
Secondary
| Measure | Time frame |
|---|---|
| Waking Sleep Awareness Questionnaire (MA version) At what time did you fall asleep last night? At what time did you wake up this morning? How many hours of sleep did you get last night? Example Entry date: Monday ID: I'm still tired I'm not tired Entry field 1. tiredness remains tiredness is gone 2. I have concentration I have no concentration 3. had a good sleep did not have a good sleep 4. feeling liberated feeling stressed 5. my body feels lazy my body feels crisp 6. have an appetite have no appetite 7. was out of bed a lot before falling asleep was out of bed a little before falling asleep 8. clear-headedness fuzzy-headedness 9. had many nightmares had no nightmares 10. had a good night's sleep had a bad night's sleep 11. felt uncomfortable felt refreshed 12. dreamed a lot dream a little 13. woke up a lot during sleep did not wake up during sleep 14. can answer a survey quickly now answering is troublesome 15. had a long sleep had a short sleep 16. slept lightly slept deeply | — |
Countries
Japan
Contacts
Public ContactShoji Fukusumi
University of Tsukuba International Institute for Integrative Sleep Medicine
Outcome results
None listed