Research on Sleep data and Biomarkers of Insomnia Patient: a Cross-sectional Study

Not Applicable

Conditions: Diseases of the nervous system

Registration Number: KCT0009489

Lead Sponsor: Pusan National University Korean Medicine Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1) Since this study is a research study on the characteristics of insomnia patients, the sample size is set to 100 by setting the margin of error (sample error) of 9.8% as the number of samples considering the budget when applying the sample number formula from the perspective of the research study.
2) On the other hand, if the number of samples for correlation analysis between the biomarkers of insomnia patients and various indicators related to sleep (such as sleep disturbance, quality of life, and core emotion scale) is applied, it is calculated as 84 when the significance level is 5%, the power is 80%, and the medium effect size (= correlation coefficient) is considered (= 0.3), and 93 when the dropout rate is considered.
3) Considering the above two methods, the number of samples is conservatively determined and set at 100.

Exclusion Criteria

1) Those with unstable (uncontrollable) schizophrenia, bipolar disorder, delusional disorder, etc. in the last 6 months or with an anxiety or depression score of 11 or higher on the Hospital Anxiety and Depression Scale (HADS)
2) Anyone using the C-PAP tool within the last 3 months
3) Those diagnosed with severe chronic diseases, organic lesions of the brain (brain tumors, stroke, epilepsy) or long-term diseases (malignant tumors, tuberculosis, chronic liver disease, chronic kidney disease, chronic heart disease, other rare metabolic diseases, hereditary diseases, hormonal disorders, etc.)
4) Any person who has participated in any other clinical trial with intervention within four weeks of the date of consent
5) A person who has a clear pain enough to disturb sleep or a disease that can cause sleeplessness
6) a woman who is pregnant, likely pregnant, or menstruating
7) If other clinical research personnel determine that it is not appropriate