Visualization of Sleep Structure Using Sleep Electroencephalography in Association with Well-Being

UMIN ID: UMIN000049888

Registered date:27/12/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: healthy individuals
• Date of first enrollment: 2022/12/12
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 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.]
• Secondary Outcome: 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.)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Department of Clinical Psychology, ShigakukanUniversity.
• Source(s) of Monetary Support: Shigakukan University